Recall Z-2550-2014 ยท HRS Plate, Fixation, Bone
Zimmer, Inc.
Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H TUBE&SCP PLT 135DX8H TUBE&SCP PLT 135DX10H TUBE&SCP PLT 135DX12H TUBE&SCP PLT 135DX14H TUBE&SCP PLT 140DX8H TUBE&SCP PLT 140DX10H TUBE&SCP
| Date | Aug 26, 2014 (initiated Jul 22, 2014) |
| Status | Terminated |
| Reason | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost. |
| Root cause | Package design/selection |
| Action | Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice. |
| Quantity | 972,125 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K830196 | CORSTREN COMPRESSION TUBE & PLATE Zimmer, Inc., Mar 25, 1983 |