FDA Medical Device Recalls (openFDA)
Stryker Biotech: 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
- Recall number
- Z-2311-2008
- Recalling firm
- Stryker Biotech
- 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
- Status
- Terminated
- Initiated
- 2008-06-24
- Posted
- 2008-09-20
- Terminated
- 2008-10-16
- Reason
- Product Package Insert misprint-text offset
- Root 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
- 803 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lots Numbers: FC0803004, FC0803005, FC0804002, FC0804007, FCO804010, FC0805002, FC0805003, and FC0805004
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MPW
- Firm FEI
- 1000513212
- Firm city
- Hopkinton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28