The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0811-2022·Announced 2022-03-30

Biomet Fibula Composite Locking Plate Recall Due to Sterile Barrier Packaging Defect

Biomet is recalling TRAUMA A.L.P.S. fibula composite locking plates due to packaging that may not maintain sterile barrier integrity, posing a risk of infection if used.

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 no reported illnesses or injuries. The recall addresses a risk-of-harm condition where sterile barrier compromise poses infection risk without actual reported harm, fitting the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomet, Inc. is recalling BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE (Item # 856204008) due to a packaging defect. The vacuum-sealed nylon pouches may not have sufficient adhesion on all sides, potentially compromising the sterile barrier integrity.

Use of devices with compromised sterile barriers poses a risk of infection. If infection occurs, it could lead to surgical intervention or require extension of surgery to replace the affected component.

The recall affects 12 units distributed worldwide, including 28 U.S. states (AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MS, NC, NE, NM, NY, OH, OK, OR, SC, TX, UT, WA, WY), Australia, Japan, and the Netherlands. Lot #913430 is affected.

Patients or healthcare providers who have received one of these devices should contact their healthcare provider or Biomet for further guidance.

The recalled product

Product
BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
12

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 # 913430
  • UDI:(01)00887868445897(17)310616(10)913430

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 →

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