Class 3 Device Recall Stryker Biotech

• Date Initiated by Firm: June 24, 2008
• Date Posted: September 20, 2008
• Recall Status: Terminated on October 16, 2008
• Recall Number: Z-2311-2008
• Recall Event ID: 48737
• HDE Number: H010002
• Product Classification: Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - Product Code MPW
• Product: 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
• Code Information: Lots Numbers: FC0803004, FC0803005, FC0804002, FC0804007, FCO804010, FC0805002, FC0805003, and FC0805004
• Recalling Firm/ Manufacturer: Stryker Biotech; 35 South St; Hopkinton MA 01748-2218
• For Additional Information Contact: Terry McGovern; 508-478-5200
• Manufacturer Reason for Recall: Product Package Insert misprint-text offset
• FDA Determined Cause: Error in labeling
• 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.
• Quantity in Commerce: 803 units
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• HDE Database: HDEs with Product Code = MPW