Recall Z-1637-2013— 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: TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. 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
TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. 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.