Recalls / —

—#132897

Product

Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400

FDA product code

KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K120121

Affected lot / code info

Part Number: 010000589 Lot: 527400

Why it was recalled

The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.

Root cause (FDA determination)

Process control

Action the firm took

Biomet issued written notices on 1/7/2015, Requested completion and submission of response/effectiveness forms for Product Part Number: 01 0000589 Product Description: Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adapter, Expiration October 2024. Questions related to this notice should be directed to Audrey Daenzer, Field Action Specialist (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

Domestic: AL, FL, NY, TX Foreign: None

Timeline

Recall initiated

2015-01-07

Posted by FDA

2015-02-24

Terminated

2015-10-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #132897. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.