Z-1297-2008

Stryker Orthopaedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non Sterile,Titanium...

Name: Z-1297-2008 Stryker Orthopaedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non Sterile,Titanium...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2008-01-28
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-01-28 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non Sterile,Titanium Alloy; Manufactured and Distributed by: Stryker... on 2008-01-28. The reason FDA records is "Screws do not have locking threads". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1297-2008
Status: Terminated
Initiated: 2008-01-28
Posted: 2008-03-25
Terminated: 2008-06-04
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non Sterile,Titanium Alloy; Manufactured and Distributed by: Stryker Leibinger GmbH & Co. KG;Boetzinger Strasse 41; 0-79111 Freiburg, Germany
Product code: HRS Plate, Fixation, Bone
Reason for recall: Screws do not have locking threads
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall notification letters (Urgent Product Recall) were sent on January 28, 2008 to all Stryker Branches/Agencies by Federal Express. All product distributed was requested to be located and returned, including from hospitals.
Quantity in commerce: 100 units
Distribution: Nationwide-USA including states of MA, PA, GA, OH, and TX (hospital consignees) and Stryker Branches/Agencies in MA, NJ, PA, MD, VA, NC, GA, TN, KY, OH, MI, LK, OK, TX, and CA.
Product codes and lots: Lot Numbers: H8W00F0B41; H9H00FB41, and H9R00F0B41

Product code HRS

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

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)