Biomet Recalls Crosslock DVR ePAK Surgical Sets Due to Oxidation Risk
Biomet is recalling 21,268 Crosslock DVR ePAK surgical sets because components may oxidize during storage. This could cause an inflammatory reaction if material enters the surgical wound.
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Biomet, Inc. is recalling 21,268 units of the Crosslock DVR ePAK -Sterile, Ref 81180050. These are complete surgical sets containing plates, screws, and instruments intended for orthopedic fixation of fractures, malunions, and osteotomies involving the distal radius and other small bones. The affected products were distributed worldwide, including in the United States, Canada, Australia, Japan, Korea, the Netherlands, Panama, Ecuador, and Chile.
The recall is due to a risk that components of the ePAKs may oxidize during shipment and storage prior to use. If oxidative material flakes off a component and enters the surgical field or wound, it may cause an inflammatory reaction, which could result in a foreign body reaction and/or metal hypersensitivity. The source notes that oxidized components have failed cytotoxicity testing. A delay in surgery of less than 30 minutes may occur if surgical staff proceeds to re-sterilize the product.
The recalled product
- Product
- Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radiu
- Manufacturer
- Biomet, Inc.
- Affected units
- 21,268
Distribution
Distributed nationwide across the United States.
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