FDA Device recall Z-0350-2017

TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 7…

FDA Device
Class II
terminated
Published 2016-11-09

On 2016-11-09 the FDA classified a Class II recall of TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 7… by Smith And Nephew, citing some Bipolar shells were manufactured with an out of specification retainer groove.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0350-2017
Classification	Class II
Status	terminated
Initiated	2016-08-29
Published	2016-11-09
Last updated	2026-09-13 11:54 UTC
Company	Smith And Nephew
Distribution	US

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

Reason

Some Bipolar shells were manufactured with an out of specification retainer groove.

Identifiers

code_info	REF NUMBER 71322040 Serial Numbers: 14AM13511, 14AM13511A REF NUMBER 71322041 Serial Numbers: 14AM21654 REF N… REF NUMBER 71322040 Serial Numbers: 14AM13511, 14AM13511A REF NUMBER 71322041 Serial Numbers: 14AM21654 REF NUMBER 71322042 Serial Numbers: 13LM06353, 13MM17938, 13MM17940, 14AM01852, 14AM04660, 14AM04662, 13LM06354, 13MM17939 REF NUMBER 71322043 Serial Numbers: 13KM21801, 13LM09191, 13MM09504, 14AM01946, 14AM04663, 14BM15318, 13LM06356, 13LM09204, 13MM09507, 14AM02029, 14AM21664, 14BM15318A, 13LM06356A, 13MM02843, 14AM01855, 14AM02046, 14BM01137, 14BM19345 REF NUMBER 71322044 Serial Numbers: 13KM21825, 13LM09225, 13MM09510, 14AM02112, 14AM04670, 14BM08940A, 13KM24083, 13LM09236, 13MM09517, 14AM02118, 14AM13546, 13KM24083A, 13LM09236A, 13MM09517A, 14AM02120, 14BM01133, 13KM24084, 13MM02853, 13MM09517B, 14AM02120A, 14BM01133A, 13LM06357, 13MM02857, 13MM14125, 14AM04667, 14BM08938, 13LM06361, 13MM02857A, 13MM14135, 14AM04668, 14BM08940 REF NUMBER 71322045 Serial Numbers: 13KM17382, 13KM24087, 13MM02862A, 13MM17942, 14AM04672, 14BM08950, 13KM21826, 13L

code_info

REF NUMBER 71322040 Serial Numbers: 14AM13511, 14AM13511A REF NUMBER 71322041 Serial Numbers: 14AM21654 REF N…

REF NUMBER 71322040 Serial Numbers: 14AM13511, 14AM13511A REF NUMBER 71322041 Serial Numbers: 14AM21654 REF NUMBER 71322042 Serial Numbers: 13LM06353, 13MM17938, 13MM17940, 14AM01852, 14AM04660, 14AM04662, 13LM06354, 13MM17939 REF NUMBER 71322043 Serial Numbers: 13KM21801, 13LM09191, 13MM09504, 14AM01946, 14AM04663, 14BM15318, 13LM06356, 13LM09204, 13MM09507, 14AM02029, 14AM21664, 14BM15318A, 13LM06356A, 13MM02843, 14AM01855, 14AM02046, 14BM01137, 14BM19345 REF NUMBER 71322044 Serial Numbers: 13KM21825, 13LM09225, 13MM09510, 14AM02112, 14AM04670, 14BM08940A, 13KM24083, 13LM09236, 13MM09517, 14AM02118, 14AM13546, 13KM24083A, 13LM09236A, 13MM09517A, 14AM02120, 14BM01133, 13KM24084, 13MM02853, 13MM09517B, 14AM02120A, 14BM01133A, 13LM06357, 13MM02857, 13MM14125, 14AM04667, 14BM08938, 13LM06361, 13MM02857A, 13MM14135, 14AM04668, 14BM08940 REF NUMBER 71322045 Serial Numbers: 13KM17382, 13KM24087, 13MM02862A, 13MM17942, 14AM04672, 14BM08950, 13KM21826, 13L

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0350-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.