Z-2311-2008

Stryker Biotech OP- 1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone...

Name: Z-2311-2008 Stryker Biotech OP- 1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone...
Creator: Stryker Biotech
Published: 2008-06-24
License: https://open.fda.gov/license/

Stryker Biotech / initiated 2008-06-24 / Terminated / root cause: labeling and UDI

FDA source

Stryker Biotech began a recall of 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... on 2008-06-24. The reason FDA records is "Product Package Insert misprint-text offset". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2311-2008
Status: Terminated
Initiated: 2008-06-24
Posted: 2008-09-20
Terminated: 2008-10-16
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
Product code: MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
Reason for recall: Product Package Insert misprint-text offset
Root cause tag: labeling and UDI
FDA 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 in commerce: 803 units
Distribution: Nationwide
Product codes and lots: Lots Numbers: FC0803004, FC0803005, FC0804002, FC0804007, FCO804010, FC0805002, FC0805003, and FC0805004

Product code MPW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)