The Recall Desk
ModerateFDA (Devices)·Z-1661-2020·Announced 2020-04-15

Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes 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, and the source text describes a process monitoring issue without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Biomet, Inc. is recalling the BIOMET StageOne Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414. The recall involves 230,001 units that were distributed worldwide, including to numerous states in the United 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 may affect the sterility or cleanliness of the medical device.

Healthcare providers and facilities that have received these devices should stop using them and contact Biomet, Inc. for further instructions on how to return or dispose of the affected units.

The recalled product

Product
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
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*** 860990
  • 215460
  • 555600
  • 583870
  • 089720
  • 283410
  • 657770
  • 148690
  • 412910
  • 181860
  • 357240
  • 409510
  • 409570
  • 196740
  • 234330
  • 338970
  • 816850
  • 723210
  • 262260
  • 039780

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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