The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1640-2020·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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 indicates a situation where use of the product could cause temporary or medically reversible adverse health consequences. The hazard is a process monitoring issue rather than a confirmed defect causing injury, fitting the Moderate criteria for low-risk contamination or voluntary precautionary measures.

Plain-English summary

Biomet, Inc. is recalling the BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183. The recall was initiated due to 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 source text does not specify the exact number of units recalled or the specific dates of distribution.

Consumers and healthcare providers should check their inventory for the specific 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. or the distributor according to the instructions provided in the recall communication.

The recalled product

Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
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*** 082090
  • 651800
  • 982380
  • 809020
  • 320900
  • 623230
  • 623240
  • 630160
  • 636040
  • 823140
  • 234220
  • 370430
  • 556610
  • 047420
  • 846270
  • 270160
  • 374980
  • 382930
  • 508920
  • 419300

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 →

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