—#74754

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: lot code 326081; and lot code 327081.

Why it was recalled

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

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2008-10-22
Posted by FDA: 2009-01-23
Terminated: 2009-07-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74754. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.