The Recall Desk
HighFDA (Devices)·Z-1647-2020·Announced 2020-04-15

Biomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns

Biomet is recalling 230,001 hip stem 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, which indicates a reasonable probability of temporary or medically reversible adverse 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, 17 X 165 MM, Silicone, Sterile, Item 431194. 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 and in the United States to 49 states and the District of Columbia. The recall includes specific lot numbers and UDI numbers listed in the official FDA record Z-1647-2020.

This is an FDA Class II recall. Consumers and healthcare providers should check their inventory for the specific lot numbers and UDI numbers provided in the recall notice and contact Biomet, Inc. for further instructions on how to return or replace the affected devices.

The recalled product

Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
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*** 978860
  • 087790
  • 087800
  • 157940
  • 558560
  • 564460
  • 052410
  • 052420
  • 052430
  • 052470
  • 052480
  • 230620
  • 230650
  • 575290
  • 767190
  • 766930
  • 789110
  • 031190
  • 031210
  • 031320

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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