The Recall Desk
ModerateFDA (Devices)·Z-1659-2020·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, which typically corresponds to a Moderate severity score (2) in the absence of reported injuries or hospitalizations, as the hazard is a process monitoring issue rather than a confirmed defect causing harm.

Plain-English summary

Biomet, Inc. is recalling the BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410. The recall involves 230,001 units distributed worldwide, including to numerous US states and the District of Columbia.

The reason for the recall is a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. This is an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and facilities should check their inventory for the affected lot numbers and UDI numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to Biomet, Inc. according to their instructions. Patients who have already received implants using these molds should contact their healthcare provider for guidance.

The recalled product

Product
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
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*** 860790
  • 215440
  • 381650
  • 555570
  • 089680
  • 283390
  • 509720
  • 657620
  • 132830
  • 372720
  • 097250
  • 281740
  • 409230
  • 409310
  • 409330
  • 196720
  • 196730
  • 338940
  • 452050
  • 581680

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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