| ||Class 2 Recall|
Howmedica Osteonics Corp.
||May 01, 2013
||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."
||Catalog number 703615
|Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
|For Additional Information Contact
||Ms. Colleen O'Meara
|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.
||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
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
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
||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.