The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1644-2020·Announced 2020-04-15

Biomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns

Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes and inadequate monitoring.

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 health consequences. The source text describes a process monitoring issue without reporting specific injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Biomet, Inc. is recalling 230,001 units of the BIOMET StageOne Select Hip Stem Cement Spacer Mold with Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191. The recall is being conducted 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 source text does not specify the exact number of affected units in the US or the specific dates of distribution.

Consumers and healthcare providers should stop using the affected devices and contact Biomet, Inc. for further instructions on how to return or replace the products.

The recalled product

Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
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*** 996010
  • 795510
  • 603900
  • 891790
  • 437190
  • 735730
  • 403040
  • 474110
  • 766880
  • 819080
  • 949560
  • 982930
  • 063520
  • 277390
  • 348170
  • 649140
  • 649130
  • 915350
  • 093590
  • 167540

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.

See all →

Same hazard · inadequate cleaning

See all →

Similar recalls