The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1660-2020·Announced 2020-04-15

Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

Biomet, Inc. is recalling 230,001 units of StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes 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 3/5 (High).

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 corresponds to a High severity score. The hazard involves a potentially insufficient cleaning process for a sterile medical device, which poses a risk of harm, but the source text does not report any specific illnesses or injuries.

Plain-English summary

Biomet, Inc. is recalling 230,001 units of the BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412. 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 the following US states: 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. Specific lot numbers and UDI numbers are listed in the official recall record.

Healthcare providers and facilities should check their inventory for the affected lot numbers and UDI numbers. If the product is found, it should be removed from use and returned to Biomet, Inc. or the distributor in accordance with the recall instructions.

The recalled product

Product
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
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*** 860910
  • 215450
  • 555580
  • 583860
  • 089700
  • 102920
  • 283420
  • 148680
  • 503890
  • 954890
  • 097260
  • 325340
  • 409370
  • 409450
  • 409490
  • 851280
  • 234350
  • 452060
  • 706850
  • 257410

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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