Z-0036-2010

ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is...

Name: Z-0036-2010 ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is...
Creator: Alphatec Spine, Inc.
Published: 2008-12-16
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2008-12-16 / Terminated / root cause: manufacturing process

FDA source

Alphatec Spine, Inc. began a recall of ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants on 2008-12-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0036-2010
Status: Terminated
Initiated: 2008-12-16
Posted: 2009-10-08
Terminated: 2009-11-13
Recalling firm: Alphatec Spine, Inc.
Product: ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Product code: LRP Tray, Surgical
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 7 Screws
Distribution: Nationwide Distribution -- Including states of TX, FL, & NJ.
Product codes and lots: Lot Number: 53298

Product code LRP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)