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
This recall has been terminated (originally issued September 20, 2008).
- Company
- Stryker Biotech
- Recall Initiated
- June 24, 2008
- Posted
- September 20, 2008
- Terminated
- October 16, 2008
- Recall Number
- Z-2311-2008
- Quantity
- 803 units
- Firm Location
- Hopkinton, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Product Package Insert misprint-text offset
Distribution
Nationwide
Lot / Code Info
Lots Numbers: FC0803004, FC0803005, FC0804002, FC0804007, FCO804010, FC0805002, FC0805003, and FC0805004
Root Cause
Error in labeling
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.