Recall Z-0474-2013 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Biomet, Inc.
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
| Date | Dec 5, 2012 (initiated Nov 1, 2012) |
| Status | Terminated |
| Reason | The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life. |
| Root cause | Process control |
| Action | Biomet, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 1, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The notification letter instructed the surgeon to montior the patient as their is a potential for increased wear which have an unknown effect on implant life. For questions call 574-372-1570. |
| Quantity | 4 |
| Distribution | USA Nationwide Distribution in the state of WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030710 | BIO-MODULAR SHOULDER SYSTEM Biomet, Inc., Jun 4, 2003 |