Recall Z-1547-05 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Linvatec Corp.
Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121 QTY 1 3.5mm Bio-Anchor with Disposable Driver***STERILE***Linvatec A ConMed Company LINVATEC CORPORATION LARGO, FL 33773 USA***''.
| Date | Sep 21, 2005 (initiated Feb 22, 2005) |
| Status | Terminated |
| Reason | Linvatec has determined that there is a possibility that the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for compromised sterility of the devices. |
| Root cause | Other |
| Action | Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method. |
| Quantity | 1,055 Units |
| Distribution | Product was shipped to consignees and customers (sales representatives, domestic customers, international customers, and international distributors and affiliates). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033804 | BIOANCHOR WITH DISPOSABLE DRIVER Linvatec Corp., Dec 31, 2003 |