| Class 2 Device Recall Howmedica Osteonics Corp. | |
Date Initiated by Firm | March 28, 2013 |
Date Posted | May 01, 2013 |
Recall Status1 |
Terminated 3 on November 17, 2015 |
Recall Number | Z-1210-2013 |
Recall Event ID |
64942 |
Product Classification |
Bit, Drill - Product Code HTW
|
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." |
Code Information |
Catalog number 703615 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah NJ 07430
|
For Additional Information Contact | Ms. Colleen O'Meara 201-831-5970 |
Manufacturer 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. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|