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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79817

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 09, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Medical Division of Stryker Corporation

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

2 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 2

6376 M-1 Cot Fastener, catalog no. 6376000000

Z-1598-2018
Recall number
Z-1598-2018
Initiated
March 09, 2018
Classification
Class II
Status
Terminated
Quantity
59

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

Code information

Serial No. 170740300 170740301 170740302 170740303 170740304 170740305 170740306 170740307 170740308 170740309 170740310 170740311 170740312 170740313 170740314 170740315 170740316 170740317 170740318 170740319 170740320 170740321 170740322 170740323 170740324 170740325 170740326 170740327 170740328 170740329 170740330 170740331 170740332 170740333 170740334 170740335 170740336 170740337 170740338 170740339 170740340 170740341 170740342 170740343 170740344 170740345 170740346 170740347 170740348 170740349 170740350 170740351 170740352 170740353 170740354 170740355 170740356 170740357 170740358

Distribution pattern

Product distributed to the Netherlands

device · product 2 of 2

6381 M-1 Cot Fastener, catalog no. 6381000000

Z-1599-2018
Recall number
Z-1599-2018
Initiated
March 09, 2018
Classification
Class II
Status
Terminated
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

Code information

Serial No. 170740538 170740539 170740540

Distribution pattern

Product distributed to the Netherlands

Field note

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