Recall Z-1635-2013— Surgical Instrument Service And Savings, Inc.
Class II · Terminated
Class II FDA medical device recall by Surgical Instrument Service And Savings, Inc., initiated 2013-05-03, terminated 2013-07-11. FDA's recall record names no specific 510(k) clearance for this event. Product: - 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: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch..
- Recalling firm
- Surgical Instrument Service And Savings, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-03
- Terminated
- 2013-07-11
- Firm location
- Redmond, OR, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.