—#99802

Product

Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, single use, REF 115345, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

FDA product code: KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K080642
Affected lot / code info: M016170, M075380, M132040, M153440, M216030, M436800, M482790, M482810, M482820, M482830, M513600, M513610, M513620, M559110, M597720, M620280, M696340, M698060, M717560, M717570, M732600, M788700, M858260, M865130, M906860, M950410, M964940 and M987720.

Why it was recalled

The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.

Root cause (FDA determination)

Employee error

Action the firm took

The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580. Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) including: Puerto Rico and countries including: Australia, Canada, Chile, Columbia, Costa Rica, Korea and Netherlands.

Timeline

Recall initiated: 2011-04-22
Posted by FDA: 2011-06-09
Terminated: 2013-02-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99802. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.