BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.
This recall has been terminated (originally issued January 9, 2007).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- November 10, 2006
- Posted
- January 9, 2007
- Terminated
- April 16, 2008
- Recall Number
- Z-0466-2007
- Quantity
- 107 in US.
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.
Distribution
Nationwide to distributors, hospitals and Integra Sales Reps.
Lot / Code Info
Model/Catalog number: 159004ND Lot Number: D2CJ/; D2CJ/1; D2PS; E0X4; E14K; E14L; E14M; E14N; E1KM; E1KN; E1X2; E24S; E2JS; E2LP.
Root Cause
Other
Action Taken
An Urgent Recall Notice was sent on 11/10/2006 to both hospitals/distributors and sales representatives by first class mail.