The Recall Desk
HighFDA (Devices)·Z-1641-2020·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 or inadequate monitoring of cleaning parameters.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device where the risk of harm (infection from inadequate cleaning) is significant, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Biomet, Inc. is recalling the BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184. The recall was initiated because of a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

The affected products were distributed worldwide, including to numerous states in the United States. The recall covers specific lot numbers and UDI numbers listed in the official FDA record. The total quantity of units involved is 230,001.

Consumers and healthcare providers should check their inventory for the specific lot numbers and UDI numbers associated with this recall. If the product is found, it should be removed from use and returned to Biomet, Inc. according to the instructions provided by the manufacturer.

The recalled product

Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard

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*** 104420
  • 982400
  • 982410
  • 321650
  • 321010
  • 623250
  • 922960
  • 031220
  • 997610
  • 556620
  • 122900
  • 382940
  • 419310
  • 474090
  • 758580
  • 009860
  • 913730
  • 188870
  • 640320
  • 790260

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 · infection risk

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