Z-1063-2009

AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set. REF 702749. This product is non sterile...

Name: Z-1063-2009 AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set. REF 702749. This product is non sterile...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2008-11-24
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-11-24 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set. REF 702749. This product is non sterile. Distributed in the USA by Howmedica Osteonics Corp... on 2008-11-24. The reason FDA records is "Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1063-2009
Status: Terminated
Initiated: 2008-11-24
Posted: 2009-04-13
Terminated: 2010-04-06
Recalling firm: Howmedica Osteonics Corp
Product: AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set. REF 702749. This product is non sterile. Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ. The torque limiter is used for final tightening locking screws to the plate in order to avoid over tightening of the locking screws.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.
FDA root cause: Other
Action: "Urgent Product Recall" letters were sent to Stryker Orthopaedics Branches/Agencies, Chief of Orthopaedics, Hospital Risk Management and Surgeons on November 24, 2008 via Federal Express. The letters described the issue and provided the following instructions: 1. Examine your inventory and determine if you have any of the affected product, 2. Remove and quarantine affected product from your inventory, 3. Complete the attached Product Recall Acknowledgement Form (and fax to Stryker Orthopaedics at 201-831-6069), and 4. Return the affected product to your Stryker Orthopaedics Sales representative. Direct questions to your Stryker Orthopaedics Sales Representative or call Stryker Orthopaedics at 201-831-5000.
Quantity in commerce: 415 units
Distribution: Nationwide Distribution.
Product codes and lots: All lot codes.

Product code HRS

K061012Class IIAxsos Plus Locking Plate SystemHowmedica Osteonics Corp. / cleared 2006-05-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)