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Terminated

Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

FDA Recall Z-0874-2016 · Posted 2016-02-25

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMAY
Date Initiated2016-01-21
Date Terminated2017-06-08
Product Quantity147,838 units in total

Reason for Recall

During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

Firm Action

Stryker Orthopaedics sent an Urgent Medical Device Removal letter and Customer Response forms dated January 21, 2016 through UPS. The letter identified the affected product, problem, actions to be taken including forwarding notice if applicable, returning all affected products and completing and returning the Customer Response form to Stericycle.by the instructions provided.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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