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Terminated

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

FDA Recall Z-0650-2016 · Posted 2016-01-13

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLZO
Date Initiated2015-11-17
Date Terminated2016-07-05
Product Quantity21

Reason for Recall

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

Firm Action

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.

Root Cause

Labeling Change Control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K942479INTEGRAL CO-CR FEMORAL COMPONENTBiomet, Inc. · 1994-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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