Linvatec Corp.
Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF***QTY 1 BioScrew XtraLok ***STERILE***Linvatec, LINVATEC CORPORATION LARGO, FL 33773 USA***''.
| Date | Sep 21, 2005 (initiated Feb 22, 2005) |
| Status | Terminated |
| Reason | Linvatec has determined there is a possibility 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 | 3,273 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
| K013131 | BIOSCREW XTRALOK Linvatec Corp., Jun 11, 2002 |