Z-1210-2013Class II

Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to...

Name: Z-1210-2013 Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2013-03-28
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-03-28 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the... on 2013-03-28. FDA classified it as Class II and gives the reason as "Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat , manufactured by Stryker Osteosynthesis, is incorrect. The incorrect scale could result in the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1210-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-28
Posted: 2013-05-01
Terminated: 2015-11-17
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm Drill (REF 702743) is then used to drill the core hole for the locking screw. Using a fluoroscopy, check the correct depth of the drill, and measure the length of the screw. The Drill Sleeve should now be removed, and the correct length 5.0 mm Locking Screw is inserted using the Screwdriver T20 and Screw Holding Sleeve."
Product code: HTW Bit, Drill
Reason for recall: Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat , manufactured by Stryker Osteosynthesis, is incorrect. The incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker Orthopaedics sent a Urgent Medical Device Removal letter dated March 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Please inform users of this Medical Device Removal and pass this notice to all those individuals who need to be aware within your organization. 2. Return all affected products available at your location to Stryker Osteosynthesis or Contact Stryker Customer Service. 3. Complete and sign the enclosed Business Reply Form and fax a copy to: 1-865-252-3635 . 4. Keep a copy of the completed and executed Business Reply Form for your records. Report any adverse events or product quality problems to Stryker Orthopaedics: 1-866-0R-ASSIST. (1-866-672-7747). As we strive for products that meet your expectations for quality and reliability, please do not hesitate to contact us, in case you have any further questions at (201) 831-5970..
Quantity in commerce: 107 units
Distribution: Nationwide Distribution including the states of AL, AZ, IL, KY, LA, NJ, NC, FL, CA, NM, MO, TN, VA, CO, MA, TX, IN and MT.
Product codes and lots: Catalog number 703615

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1210-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1210-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-05-01

Product code HTW

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