Recall Z-0036-2010 ยท LRP Tray, Surgical
Alphatec Spine, Inc.
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
| Date | Oct 8, 2009 (initiated Dec 16, 2008) |
| Status | Terminated |
| Reason | Alphatec discovered that the lot of bolt caddies had the incorrect bolt length laser etched on one side of the caddy. The actual ROC bolts themselves are correctly laser etched. |
| Root cause | Employee error |
| Action | Alphatec contacted consignees via phone on December 16, 2008 and informed consignees that they will arrange to have Federal Express contact them for pick-up. Consignees were asked to check their inventory to see where this product is located, and ensure that it is put on hold for return; and what days and hours they are in the office, (Confirm address: attach copy of the pick-up request form.) If they have any follow up questions, they were told to call 1-800-922-1356. |
| Quantity | 7 Screws |
| Distribution | Nationwide Distribution -- Including states of TX, FL, & NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.