Agency classClass IIOur severity:High FDA (Devices)·Z-0810-2022·Announced 2022-03-30

BIOMET Trauma DVR CROSSLOCK implants recalled for packaging integrity

BIOMET Trauma DVR CROSSLOCK surgical implant plates may have packaging that does not maintain sterile barrier integrity, posing a risk of infection.

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: FDA Class II device with potential for serious infection risk due to compromised sterile barrier integrity. No illnesses or injuries have been reported; this is a precautionary recall for a risk-of-harm product.

Plain-English summary

BIOMET, Inc. is recalling specific lots of BIOMET Trauma DVR CROSSLOCK surgical implant plates due to packaging defects. The packaging on these devices may not have sufficient adhesion on all sides, which compromises the sterile barrier integrity required for safe use.

The recalled devices include Item #13182-22-26 (DVR CROSSLOCK EXTRA LONG PLATE LEFT), Item #1318-12-126 (DVR CROSSLOCK EXTRA LONG PLATE RIGHT), and Item #1318-12-176 (DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT). A total of 38 units have been distributed worldwide across 28 U.S. states, Australia, Japan, and the Netherlands.

Use of these devices with compromised packaging poses a risk of infection, which may require surgical intervention or extension of surgery.

The recalled product

Product: BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a…
Manufacturer: Biomet, Inc.
Category: Medical Device — Surgical Implants
Hazard: sterile-barrier-compromise
infection-risk
packaging-defect
Affected units: 38

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 (13)

6 lots: Lot #
UDI - [101220
(01)00887868446191(17)310623(10)101220]
[101340
(01)00887868446207(17)310625(10)101340]
[101450
(01)00887868446313(17)310630(10)101450]
[101560
(01)00887868446191(17)310624(10)101560]
[119180
(01)00887868446313(17)310630(10)119180]
[154060
(01)00887868446313(17)310630(10)154060]

Distribution

Distributed in 28 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 →

Same manufacturer · Biomet, Inc.

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Same hazard · sterile barrier compromise