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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96281

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 29, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
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

1 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 1

Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197

Z-1328-2025
Recall number
Z-1328-2025
Initiated
January 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Corporation
Quantity
9521 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.

Code information

UDI:07613327123661/ Lot #s: 23342AE2 24190AE2 23345AE2 24200AE2 24004AE2 24201AE2 24008AE2 24204AE2 24009AE2 24205AE2 24010AE2 24206AE2 24032AE2 24214AE2 24033AE2 24215AE2 24036AE2 24221AE2 24050AE2 24222AE2 24061AE2 24226AE2 24064AE2 24233AE2 24065AE2 24235AE2 24066AE2 24240AE2 24087AE2 24248AE2 24093AE2 24249AE2 24094AE2 24250AE2 24127AE2 24256AE2 24128AE2 24257AE2 24135AE2 24258AE2 24136AE2 24260AE2 24137AE2 24276AE2 24143AE2 24277AE2 24144AE2 24278AE2 24159AE2 24283AE2 24160AE2 24284AE2 24162AE2 24285AE2 24169AE2 24292AE2 24170AE2 24306AE2 24184AE2 24309AE2 24185AE2 24311AE2 24186AE2 24312AE2

Distribution pattern

Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Colombia, Netherlands, Spain, Mexico, Australia, United Kingdom, Brazil.