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.
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: 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.
- Hazard
- sterile-barrier-compromise
- infection-risk
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:
- 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
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