—#129028

Product

Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K093293
Affected lot / code info: Catalog Number: 32-48847 4 Lot Numbers: 022120, 022180, 162530, 232460, 475500 and 475510. 699240, 793350, 793570 Additional Scope: 065030, 095780, 164290, 235870, 253670, 273630, 308620, 418970, 420030, 421210, 570460, 585260, 619690, 708240, 711430, 726490, 816160, 896810, 929690, 953540, 968950

Why it was recalled

The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.

Root cause (FDA determination)

Process change control

Action the firm took

Urgent Medical Device Recall Notices dated July 15, 2014 were mailed with verification of delivery via FedEx. Response forms were provided to all consignees in order for Biomet to track returns. The letters informed the consignees to return the devices to Biomet and conduct a sub-recall sending the recall letter to all customers.

Recalling firm

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

Distribution

Distribution pattern: California, IA, FL, MD, UT, SC, AL, IL, CO, MA, KS, GA, WA, NV, AR, NH, OK,Pennsylvania, New York, Texas, Virginia, New Jersey, North Carolina, Kentucky, Michigan, Ohio, Wisconsin, Louisiana, Arizona, Indiana, South Dakota, Missouri & Montana. In addition to Korea, B.V., Japan, Puerto Rico, UK, Chile, New Zealand, Australia, & Canada

Timeline

Recall initiated: 2014-07-01
Posted by FDA: 2014-08-15
Terminated: 2015-10-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129028. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.