Recall events
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Event 75502
Event summary
Timeline bucket October 03, 2016
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Synthes (USA) Products LLC
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
8 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 8
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
Z-0637-2017
Recall number Z-0637-2017
Initiated October 03, 2016
Classification Class II
Status Terminated
Quantity 1,951 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0637-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15925]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Code information Catalog ID 351.707S, Lot Numbers: 9963694; 9963695; 9963696; 9963697; 9963698; 9963699; 9972862; H040500; H040502; H040503; H060093; H060094; H060095; H060096; H060097; H080022; H080023; H080024; H080025; H089873; H089874; H089875.
Distribution pattern Distributed Nationwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[20026]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 8
3.0 mm Reaming Rod/950 mm, Sterile
Z-0638-2017
Recall number Z-0638-2017
Initiated October 03, 2016
Classification Class II
Status Terminated
Quantity 887 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0638-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21267]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Code information Catalog ID 351.71S, Lot Numbers: H000111; H033314; H067857; H067858; H069074; H069079; H087019; H090015; H090747; H100713; H123976.
Distribution pattern Distributed Nationwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[23617]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 8
3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
Z-0639-2017
Recall number Z-0639-2017
Initiated October 03, 2016
Classification Class II
Status Terminated
Quantity 5478 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0639-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45075]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Code information Catalog ID 351.76S, Lot Numbers: 9938361; 9970591; H000103; H001021; H032765; H032769; H033313; H043056; H043057; H043058; H043551; H043564; H054931; H054932; H054933; H056192; H056193; H056194; H058374; H058375; H058376; H058377; H058378; H059426; H059427; H059428; H067852; H067853; H069071; H069073; H077277; H077452; H077704; H086318; H086319; H087018; H089848; H089849; H089850; H090012; H090013; H090014; H090745; H099607; H099608; H099610; H099611; H115889; H115890; H115891; H115892; H122535; H122998; H123001; H123002; H123970; H123975; H135276; H135277; H135278; H141083; H141085.
Distribution pattern Distributed Nationwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[20035]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 8
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Z-0640-2017
Recall number Z-0640-2017
Initiated October 03, 2016
Classification Class II
Status Terminated
Quantity 319 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0640-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38795]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Code information Catalog ID 355.041S, Lot Numbers: H085635; H087271; H094462; H111419; H136756
Distribution pattern Distributed Nationwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19831]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 8
2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
Z-0641-2017
Recall number Z-0641-2017
Initiated October 03, 2016
Classification Class II
Status Terminated
Quantity 139 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0641-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33915]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Code information Catalog ID 355.042S, Lot Numbers: H085634; H094463.
Distribution pattern Distributed Nationwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19256]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 8
Extraction Hook - Sterile for TI Cannulated Nails
Z-0642-2017
Recall number Z-0642-2017
Initiated October 03, 2016
Classification Class II
Status Terminated
Quantity 114 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0642-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56799]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Code information Catalog ID 355.399S, Lot Numbers: H102610
Distribution pattern Distributed Nationwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[20556]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 8
2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
Z-0643-2017
Recall number Z-0643-2017
Initiated October 03, 2016
Classification Class II
Status Terminated
Quantity 260 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0643-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45763]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Code information Catalog ID 359.083S, Lot Numbers: H115566; H116597; H116601; H117049
Distribution pattern Distributed Nationwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[20029]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 8
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
Z-0644-2017
Recall number Z-0644-2017
Initiated October 03, 2016
Classification Class II
Status Terminated
Quantity 2,157 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0644-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56788]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Code information Catalog ID 351.709S, Lot Numbers: 9913251; 9913252; 9913254; 9913256; 9913259; 9913260; 9950460; 9950461; 9950462; 9950463; 9950464; 9963747; 9963748; 9963749; 9963751; 9963752; 9963753; 9963755; 9963756; 9963757; 9985371; 9985372; 9985373; 9985374; H040508; H040509; H040510; H040511; H040512; H040517; H040518; H040519; H060103; H060104; H060105; H060106; H060107; H060108; H060114; H060115; H060116; H080034; H080035; H080036; H080037; H080038; H080039; H080040; H080041; H080081; H080082; H080083; H080084; H080085; H080086; H080087; H080088; H080089; H105527; H105528; H105529; H105530.
Distribution pattern Distributed Nationwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[20573]
FDA event record
· Exact recall-number query on openFDA
