Recall Z-1127-2013 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Synvasive Technology Inc
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both o
| Date | Apr 17, 2013 (initiated Mar 14, 2013) |
| Status | Terminated |
| Reason | Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade. |
| Root cause | Packaging change control |
| Action | An Urgent Medical Device Recall Notice letter dated March 21, 2013 was sent to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use; remove the products from inventory and complete and return the attached Response Form. For questions call 574-372-1570. |
| Quantity | 100 kits |
| Distribution | USA Nationwide Distributor including the state of IN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911902 | TEMPERLITE(TM) SAW BLADE Sierra Surgical, Inc., Jun 28, 1991 |