The Recall Desk
ModerateFDA (Devices)·Z-1658-2020·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 potential process issue without reporting specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Biomet, Inc. is recalling the BIOMET StageOne Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408. The recall was initiated because of a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Approximately 230,001 units were distributed worldwide, including to hospitals and medical facilities in the United States. The affected products are sterile silicone molds used in shoulder surgery to shape bone cement.

Biomet is working with the FDA to address the issue. Healthcare providers should stop using the affected lots and contact Biomet for further instructions. Patients who have had surgery using these devices should consult their healthcare provider if they have concerns.

The recalled product

Product
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
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*** 860710
  • 215430
  • 555230
  • 583850
  • 089660
  • 283370
  • 132850
  • 372710
  • 372760
  • 181880
  • 357230
  • 409110
  • 409190
  • 765360
  • 196690
  • 196700
  • 196710
  • 338960
  • 511930
  • 549800

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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