Z-1635-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2013
- Initiation Date
- May 3, 2013
- Termination Date
- July 11, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
- Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0 Lot 122289, 122322 - Midas Rex Metal Cutting Drill Bit 3.0mm x 18.3mm Ref. MC30 Lot 122347 Orthopedic manual surgical instrument
Reason for Recall
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Distribution Pattern
Nationwide Distribution.
Code Information
122347, 122289, 122322, 122511.