Recall Z-1210-2013 ยท HTW Bit, Drill
Stryker Howmedica Osteonics Corp.
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 t
| Date | May 1, 2013 (initiated Mar 28, 2013) |
| Status | Terminated |
| Reason | 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 | 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 comple |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.