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Terminated

Stryker Biotech OP- 1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. Catalog Number: 100-25

FDA Recall Z-2311-2008 · Posted 2008-09-20

Recalling FirmStryker Biotech
Recall StatusTerminated
Product CodeMPW
Date Initiated2008-06-24
Date Terminated2008-10-16
Product Quantity803 units

Reason for Recall

Product Package Insert misprint-text offset

Firm Action

Stryker Biotech notified by letter dated June 24, 2008 via UPS Certified Mail. Physician letters were mailed 30 Jun 2008 and IRB letters were mailed July 01, 2008; letters included a correctly printed package insert. Contact Judith Sernatinger at 508-416-5200 if you have questions.

Root Cause

Error in labeling

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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