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
Reported: November 9, 2016 Initiated: August 29, 2016 #Z-0350-2017
Product Description
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
Reason for Recall
Some Bipolar shells were manufactured with an out of specification retainer groove.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 2352 units
- Distribution
- 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
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Smith & Nephew, Inc.. Units affected: 2352 units.
Why was this product recalled? ▼
Some Bipolar shells were manufactured with an out of specification retainer groove.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 9, 2016. Severity: Moderate. Recall number: Z-0350-2017.
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