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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Brand
Alphatec Spine, Inc.
Lot Codes / Batch Numbers
Lot Number: 53298
Products Sold
Lot Number: 53298
Alphatec Spine, Inc. is recalling ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Pro due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026