—#192271

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.

FDA product code: JDR — Staple, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K111663
Affected lot / code info: Lot # 913430, UDI:(01)00887868445897(17)310616(10)913430

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

A recall notification was sent via courier 24 Feb 2022 to distributors, surgeons, and hospital risk managers. Customers advised to locate and quarantine product, return to Biomet and identify any further customers receiving product. Recalled product is identified using specific lot and item numbers. Additionally, surgeons and hospital risk managers are to follow any specified patient monitoring instructions and return the Certificate of Acknowledgement to Zimmer Biomet. If you have further questions or concerns, please call customer service at 574-371-3071 or send questions via email to CorporateQuality.PostMarket@zimmerbiomet.com

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2022-02-14
Terminated: 2024-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192271. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.