The Recall Desk
HighFDA (Devices)·Z-2551-2014·Announced 2014-09-03

Zimmer Recalls Moore & Thompson Hip Stems Due to Packaging Failures

Zimmer, Inc. is recalling Moore & Thompson Hip Stems because packaging design verification tests failed, resulting in compromised seal integrity or breached trays.

What this means for you

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 involves a risk-of-harm product (sterile implant) where packaging integrity failures could compromise sterility, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Zimmer, Inc. is recalling sterile-packaged Moore & Thompson Hip Stems and instruments. The recall involves 972,125 units distributed worldwide. The affected products include various FNSTRD HIP and HIP PROS stem configurations with item numbers ending in ST, with expiration dates prior to July 2024.

The recall was initiated due to packaging design verification test failures. Multiple test samples from six different package configurations failed simulated distribution and shipping testing. During these tests, the devices either breached inner or outer package trays or lost seal integrity. This indicates a potential risk to the sterility of the implants.

Healthcare providers and patients who have received these specific hip stem implants should contact their surgeon or Zimmer, Inc. for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP 46HDX140ST FNSTRD HIP 47HDX140ST FNSTRD HIP 48HDX140ST FNSTRD HIP 49HDX140ST
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
972,125

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)

  • Item Numbers:00400500038
  • 00400500040
  • 00400500041
  • 00400500042
  • 00400500043
  • 00400500044
  • 00400500045
  • 00400500046
  • 00400500047
  • 00400500048
  • 00400500049
  • 00400500050
  • 00400500051
  • 00400500052
  • 00400500053
  • 00400500054
  • 00400500055
  • 00400500057
  • 00400500060
  • 00400500063

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 7 recalled by Zimmer, 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 7 products in this recall →

Related recalls

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Same hazard · packaging integrity

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