The Recall Desk
HighFDA (Devices)·Z-1642-2020·Announced 2020-04-15

Biomet Recalls StageOne Hip Cement Spacer Molds Due to Cleaning Concerns

Biomet is recalling StageOne Hip Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.

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 sterility/cleaning defect, which poses a risk of harm (infection) even though specific injuries are not reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Biomet, Inc. is recalling the BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185. The recall involves 230,001 units that were distributed worldwide and to specific states in the United States.

The recall was initiated due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. This issue could affect the sterility or cleanliness of the medical device.

Healthcare providers and facilities that have received these specific lot numbers should stop using the affected devices and contact Biomet for instructions on how to return or dispose of them. Patients who have already had these devices implanted should contact their healthcare provider for guidance.

The recalled product

Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard

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*** 004800
  • 104440
  • 734050
  • 082110
  • 912150
  • 961960
  • 092470
  • 630170
  • 602290
  • 357210
  • 508930
  • 474100
  • 913740
  • 364330
  • 396650
  • 295210
  • 854280
  • 952930
  • 816110
  • 362340

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 · infection risk

See all →