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
This recall has been terminated (originally issued January 23, 2009).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- October 22, 2008
- Posted
- January 23, 2009
- Terminated
- July 15, 2009
- Recall Number
- Z-0854-2009
- Quantity
- 351 units
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
A packaging error had occurred where 16 mm screws were packaged and labeled as 12 mm screws and vice versa.
Distribution
Nationwide Distribution
Lot / Code Info
lot code 326081; and lot code 327081.
Root Cause
Packaging
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.