The Recall Desk
HighFDA (Devices)·Z-1643-2020·Announced 2020-04-15

Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

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

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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard involves a potentially insufficient cleaning process for a sterile medical device, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Biomet, Inc. is recalling 230,001 units of the BIOMET StageOne Select Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190. 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 all 50 U.S. states and the District of Columbia. The recall covers specific lot numbers and UDI numbers listed in the official FDA record Z-1643-2020.

This is an FDA Class II recall. No specific instructions for consumers are provided in the source text, but the recall indicates a potential risk related to the sterility or cleanliness of the medical device.

The recalled product

Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implants
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*** 502050
  • 628160
  • 754710
  • 795480
  • 383860
  • 938730
  • 258280
  • 258190
  • 520980
  • 794470
  • 135080
  • 407080
  • 474100
  • 333620
  • 576720
  • 739510
  • 789340
  • 949520
  • 062820
  • 233420

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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