The Recall Desk
ModerateFDA (Devices)·Z-1649-2020·Announced 2020-04-15

Biomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns

Biomet is recalling hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential process deviation (cleaning) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Biomet, Inc. is recalling the BIOMET StageOne Select Hip Stem Cement Spacer Mold with Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196. The recall involves 230,001 units that were distributed worldwide, including to all 50 U.S. states and the District of Columbia.

The recall was initiated because of 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 should check their inventory for the specific lot numbers and UDI numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to Biomet, Inc. according to their instructions.

The recalled product

Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
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*** 188860
  • 326860
  • 558630
  • 628180
  • 977670
  • 116350
  • 122520
  • 437230
  • 437290
  • 740330
  • 341070
  • 576690
  • 789080
  • 063540
  • 555070
  • 916280
  • 167510
  • 200790
  • 388910
  • 551820

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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Same hazard · sterility

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