Recalls / —

—#141358

Product

Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm

FDA product code

LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K942479

Affected lot / code info

Part #11-162709  9mm Lots: 329750, 404380, 487400, 767120, 951680 Part # 11-162711 11mm Lots: 329760, 505030, 505050 Part # 11-162713 13mm Lots: 837750, 977460 Part # 11-162715 15mm 772410, 837780, 897070, 951810 Part # 11-162717 17mm Lots: 311410, 410500, 535530, 712800, 728080, 829580

Why it was recalled

PMMA is listed as a material on the label but the product does not contain PMMA.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

On 11/17/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (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

Worldwide distribution. US nationwide including IA, UT, MN, PA, MO, OK, IL, OH, and WA; CANADA, and NETHERLANDS

Timeline

Recall initiated

2015-11-17

Posted by FDA

2016-01-13

Terminated

2016-07-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #141358. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.