FDA-Device2013-07-10Class II

TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instrument

Surgical Instrument Service And Savings, Inc.
Hazard

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Sold states
Nationwide Distribution.
Affected count
4
Manufactured in
2747 Sw 6th St, N/A, Redmond, OR, United States
Products
TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instrument

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1637-2013

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