The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0351-2017·Announced 2016-11-09

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

Smith & Nephew is recalling 5,806 Tandem hip shell units manufactured with out-of-specification retainer grooves. The recall covers distribution in the US and 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 FDA classified this as a Class II recall, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. This aligns with the 'High' severity category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smith & Nephew, Inc. is recalling 5,806 units of the TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR medical device. The recall was initiated because some of the bipolar shells were manufactured with an out-of-specification retainer groove. The affected products are identified by specific reference numbers and serial numbers listed in the recall notice.

The recalled devices 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. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients who have received these specific hip shells should contact Smith & Nephew for further instructions on how to proceed. The recall notice provides a comprehensive list of reference numbers and serial numbers to help identify the affected units.

The recalled product

Product
TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039…
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
5,806

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 71324038 Serial Numbers: 13LM19426
  • 13LM19431
  • 14BM10263
  • 14BM10264 REF NUMBER 71324039 Serial Numbers: 13LM16207
  • 14AM08786
  • 14AM08786A REF NUMBER 71324040 Serial Numbers: 13LM12963
  • 13LM17120
  • 13MM18005
  • 14BM00728
  • 14BM10265A
  • 14BM16804
  • 13LM12964
  • 13MM18000
  • 14AM02711
  • 14BM00729
  • 14BM10266
  • 14BM16815
  • 13LM16210
  • 13MM18001
  • 14AM12034

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 →

Related recalls

Same manufacturer · Smith & Nephew, Inc.

See all →

Same hazard · manufacturing defect

See all →

Similar recalls