The Recall Desk
ModerateFDA (Devices)·Z-1656-2020·Announced 2020-04-15

Biomet Hip Cement Spacer Mold Recalled for Cleaning Process Concerns

Biomet is recalling StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes and inadequate process monitoring.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text describes a potential process failure without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Biomet, Inc. is recalling the BIOMET StageOne Hip Cement Spacer Mold with Reinforcement (Item 431217). The recall involves 230,001 units distributed worldwide, including to numerous US states and the District of Columbia.

The recall was initiated because of a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. This issue could affect the sterility or cleanliness of the medical device.

Healthcare providers and patients who have received or used these specific lot numbers should contact Biomet, Inc. for further instructions on how to proceed with the recall.

The recalled product

Product
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
230,001

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)

  • ***Lot Numbers*** 919110
  • 191510
  • 414530
  • 650030
  • 931530
  • 836760
  • 836740
  • 162280
  • 162260
  • 285580
  • 285590
  • 668840
  • 036370
  • 390550
  • 613860
  • 518830
  • 555610
  • 207250
  • 913770
  • 628380

Distribution

Distributed in 49 states:

Part of a larger recall action

This product is one of 33 recalled by Biomet, 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 33 products in this recall →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · inadequate cleaning

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