The Recall Desk
ModerateFDA (Devices)·Z-1655-2020·Announced 2020-04-15

Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

Biomet, Inc. is recalling StageOne Hip Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.

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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a process monitoring issue regarding cleaning, which fits the criteria for a moderate severity voluntary precautionary recall without reported harm.

Plain-English summary

Biomet, Inc. is recalling the BIOMET StageOne Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213. The recall was initiated due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Approximately 230,001 units were distributed worldwide, including to numerous states in the United States. The affected products are sterile silicone molds used in hip surgery.

Healthcare providers and patients should contact Biomet, Inc. for further information regarding the recall and appropriate next steps for affected patients.

The recalled product

Product
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
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*** 027900
  • 670510
  • 371230
  • 836660
  • 602430
  • 008340
  • 008360
  • 008380
  • 162240
  • 162250
  • 700500
  • 186490
  • 377390
  • 658100
  • 658110
  • 658120
  • 658130
  • 473170
  • 912530
  • 086110

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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