Z-0854-2009

Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only Catalog number R6357A (12 mm)...

Name: Z-0854-2009 Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only Catalog number R6357A (12 mm)...
Creator: Integra LifeSciences Corp.
Published: 2008-10-22
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2008-10-22 / Terminated / root cause: packaging

FDA source

Integra LifeSciences Corp. began a recall of Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only Catalog number R6357A (12 mm), Catalog number R6397A (16 mm), Integra LifeSciences... on 2008-10-22. The reason FDA records is "A packaging error had occurred where 16 mm screws were packaged and labeled as 12 mm screws and vice versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0854-2009
Status: Terminated
Initiated: 2008-10-22
Posted: 2009-01-23
Terminated: 2009-07-15
Recalling firm: Integra LifeSciences Corporation
Product: Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only Catalog number R6357A (12 mm), Catalog number R6397A (16 mm), Integra LifeSciences Corp., 311 Enterprise Drive, Plainsboro, NJ 08536
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: A packaging error had occurred where 16 mm screws were packaged and labeled as 12 mm screws and vice versa.
Root cause tag: packaging
FDA root cause: Packaging
Action: Urgent: Product Recall Notification letters were sent via Fed Ex on October 22, 2008. The letter asked customers to quarantine any of the affected stock on hand and contact their local Integra Sales Representative for further assistance and for arrangement of product returns. Customers were to fill out the attached "Recall Acknowledgement and Return Form" indicating whether or not they possess any of the product identified in the letter. Additional questions can be directed to Christin Roach at 609-936-5413. A Urgent: Product Recall Second Notification dated 1/5/2009 was sent to customers providing them with additional information on the packaging error and included immediate and/or product used during surgery. This notification also requested that all surgeons be notified who were or may have been provided with any of the screws affected by this recall.
Quantity in commerce: 351 units
Distribution: Nationwide Distribution
Product codes and lots: lot code 326081; and lot code 327081.

Product code LXH

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)