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

FDA device recall Z-1210-2013 · posted 2013-05-01 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

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.

Action taken

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..

Root cause

Device Design

Status

Terminated

Product code

HTW

Quantity affected

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.

Date initiated

2013-03-28

Date posted

2013-05-01

Date terminated

2015-11-17

Location

Mahwah, NJ