The Recall Desk
HighFDA (Devices)·Z-1654-2020·Announced 2020-04-15

Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

Biomet, Inc. is recalling 230,001 units of 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 involves a medical device with a potential cleaning defect, which poses a risk of harm (infection) even though no injuries have been reported yet, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Biomet, Inc. is recalling 230,001 units of the BIOMET StageOne Hip Cement Spacer Mold with Reinforcement (9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209). 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 to specific states in the United States, including Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia. The recall covers numerous specific lot numbers and UDI numbers, which are listed in the official FDA record.

Healthcare providers and facilities 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 company's instructions. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
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*** 411170
  • 928060
  • 453050
  • 008400
  • 008780
  • 162230
  • 160450
  • 160460
  • 160470
  • 078140
  • 212600
  • 473150
  • 147200
  • 668750
  • 668810
  • 235310
  • 235260
  • 565730
  • 565740
  • 565780

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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