The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0081-2021·Announced 2020-10-14

Biomet Regenerex Primary Taper Cap Recalled for Sterilization Defect

Biomet is recalling Regenerex Primary Taper Caps because they were not properly aligned for gamma sterilization, potentially leaving them unsterilized.

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 involves a medical device that was not properly sterilized, which poses a risk of infection or harm. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.

Plain-English summary

Biomet, Inc. is recalling the Biomet Regenerex Primary Taper Cap (Item Number 141269) due to a sterilization defect. The recall involves 62 units in the United States and 176 units in foreign markets, including Canada, Finland, the Netherlands, and the United Kingdom.

The recall was initiated because the product was not properly aligned with the adequate gamma sterilization group. This misalignment resulted in the product not being properly sterilized. Specific lot numbers affected include 015800, 324440, 685300, 023900, 324440R, 696280, 058930, 389060, 821980, 200720, 418430, 890320, 313260, 646040, and 997610.

Healthcare providers and patients should check their inventory and records for these specific lot numbers. 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 Regenerex Primary Taper Cap Item Number 141269
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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