The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2146-2020·Announced 2020-06-03

Biomet Recalls Regenerex Knee Prostheses Due to Potential Endotoxin Levels

Biomet is recalling 15 units of Regenerex Series-A Patella knee prostheses due to potential endotoxin levels exceeding specifications.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving medical devices where contamination (endotoxin) poses a risk of adverse health consequences.

Plain-English summary

Biomet, Inc. is recalling 15 units of Regenerex Series-A Patella 3 Peg knee prostheses (sizes 31 MM and 37 MM). The recall is issued because of the potential presence of elevated endotoxin levels that exceed the specification limit.

The affected products were distributed worldwide, including the United States, Canada, India, Japan, Mexico, the Netherlands, Singapore, and other international locations. The specific lot numbers involved are 561760 and 091090.

Healthcare providers and patients should contact Biomet, Inc. for further instructions regarding the return or replacement of these devices. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
15

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 (2)

  • Lot Numbers: UDI Number 1) 561760 (01)00880304554412(17)211229(10)561760
  • 2) 091090 (01)00880304506084(17)211214(10)091090

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 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 13 products in this recall →

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