Stryker Biotech OP- 1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone nonunions wh
FDA device recall Z-2311-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Stryker Biotech
- Reason for recall
- Product Package Insert misprint-text offset
- Action taken
- 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
- Status
- Terminated
- Product code
- MPW
- Quantity affected
- 803 units
- Distribution
- Nationwide
- Date initiated
- 2008-06-24
- Date posted
- 2008-09-20
- Date terminated
- 2008-10-16
- Location
- Hopkinton, MA
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