Home / Recalls / Medical Devices
Smith & Nephew, Inc. recalls TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 7132204
Recalled November 9, 2016 · FDA recall Z-0350-2017 · Smith & Nephew
Hazard
Some Bipolar shells were manufactured with an out of specification retainer groove. · FDA Class II
Units
2352 units
Sold at
Nationwide and Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates
Description
Some Bipolar shells were manufactured with an out of specification retainer groove.
Product
TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →