Recalls / —

—#185324

Product

A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.

FDA product code

HRS — Plate, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K173767

Affected lot / code info

Item: 233500004; Lot: 516349, 545167; UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167

Why it was recalled

The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.

Root cause (FDA determination)

Device Design

Action the firm took

On 12/30/2020, Zimmer Biomet issued an Urgent Medical Device Recall to the consumer/user level, including any intermediate wholesale or retail consignees. All distributors will be notified via email. Hospital risk managers and surgeons, as well as distributors with product, will be notified via courier.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

Nationwide distribution.

Timeline

Recall initiated

2020-12-23

Posted by FDA

2021-01-21

Terminated

2023-04-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #185324. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.