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

FDA device recall Z-0854-2009 · posted 2009-01-23 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

A packaging error had occurred where 16 mm screws were packaged and labeled as 12 mm screws and vice versa.

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

LXH

Quantity affected

351 units

Distribution

Nationwide Distribution

Date initiated

2008-10-22

Date posted

2009-01-23

Date terminated

2009-07-15

Location

Plainsboro, NJ