Recall Z-0854-2009 ยท LXH Orthopedic Manual Surgical Instrument
Integra LifeSciences Corp.
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
| Date | Jan 23, 2009 (initiated Oct 22, 2008) |
| Status | Terminated |
| Reason | A packaging error had occurred where 16 mm screws were packaged and labeled as 12 mm screws and vice versa. |
| 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 |
| Quantity | 351 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.