Biomet, Inc.: 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

Is my product affected?

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.

• UPC 00887868445897

Check against the official notice below — it lists the full affected range.

What happened

Biomet, Inc. is recalling 12 units of the BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE (Item # 856204008) from Lot # 913430. The implant devices are packaged in vacuum-sealed nylon pouches placed in cartons with instructions for use. The packaging may not have sufficient adhesion on all sides, which could compromise the sterile barrier.

If the sterile barrier is compromised, use of the product poses a risk of infection that could lead to surgical intervention or extension of surgery to locate an alternative part. The affected devices were distributed worldwide, including to 28 U.S. states and internationally to Australia, Japan, and the Netherlands. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.

Details from the source

Reason for recall: Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part. Distribution: Worldwide: US (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), Australia, Japan, and Netherlands Quantity: 12 Lot/code info: Lot # 913430, UDI:(01)00887868445897(17)310616(10)913430

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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