Recall Z-1092-2014 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Zimmer, Inc.
00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder prosthetic replacement device that is indicated for the treatment of severe pain or significant disability in degenerative, rh
| Date | Feb 26, 2014 (initiated Jan 10, 2014) |
| Status | Terminated |
| Reason | This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum required by specification in one of the three zones of the Trabecular Metal. The other two zones exceeded the minimum specification. |
| Root cause | Nonconforming Material/Component |
| Action | Zimmer sent an Urgent Medical Device Recall dated January 10, 2014 to distributors via electronic mail. The hospital/surgeon that has implanted this manufacturing lot will be identified and notified by the distributor. The letter identified the affected product, problem and actions to be taken. Distributors were instructed to locate and remove the affected product in their territory, as well as identifying and notifying the hospital/surgeon that has implanted this manufacturing lot as applicable. The distributor will return on-hand affected products to Zimmer and ensure all of their p |
| Quantity | 10 units |
| Distribution | Distribution USA in the state of Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041549 | ZIMMER TRABECULAR METAL HUMERAL STEM Zimmer, Inc., Sep 1, 2004 |