The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0350-2017·Announced 2016-11-09

Smith & Nephew Recalls Tandem Hip Shells With Out-of-Specification Grooves

Smith & Nephew is recalling 2,352 Tandem hip shells manufactured with out-of-specification retainer grooves. The recall covers units distributed nationwide and in 23 other countries.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Smith & Nephew, Inc. is recalling 2,352 units of the TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR hip implant. The recall was initiated because some of the affected bipolar shells were manufactured with an out-of-specification retainer groove. The affected products are identified by specific reference numbers ranging from 71322040 to 71322057 and associated serial numbers.

The affected units were distributed nationwide in the United States, as well as in Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, and the United Arab Emirates. This is an FDA Class II recall, which indicates that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients who have received these specific hip shells should contact Smith & Nephew or their healthcare provider for instructions on how to proceed. The source text does not report any specific illnesses or injuries associated with this defect.

The recalled product

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
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
2,352

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF NUMBER 71322040 Serial Numbers: 14AM13511
  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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