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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98399

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

Open FDA event record

Event summary

Timeline bucket
February 06, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
International Life Sciences

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

3 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 3

Artelon FlexBand Dynamic Matrix Ref: 31057

Z-1554-2026
Recall number
Z-1554-2026
Initiated
February 06, 2026
Classification
Class II
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Augmentation devices failed bacterial endotoxin testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Augmentation devices failed bacterial endotoxin testing.

Code information

A10011001/GTIN: 00850003396019

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.

device · product 2 of 3

Artelon FlexBand Plus Ref: 41054 & 41057

Z-1555-2026
Recall number
Z-1555-2026
Initiated
February 06, 2026
Classification
Class II
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Augmentation devices failed bacterial endotoxin testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Augmentation devices failed bacterial endotoxin testing.

Code information

REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.

device · product 3 of 3

Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)

Z-1556-2026
Recall number
Z-1556-2026
Initiated
February 06, 2026
Classification
Class II
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Augmentation devices failed bacterial endotoxin testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Augmentation devices failed bacterial endotoxin testing.

Code information

Lot: RK29976/GTIN: 00850003396248

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.

Field note

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