—#133700

Product

Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K030055
Affected lot / code info: Catalog Number: 13-104150 Lot Number Identification: 364600

Why it was recalled

Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

Root cause (FDA determination)

Packaging process control

Action the firm took

Biomet notified all domestic and foreign customers via FEDEx overnight on 1/9/2015. Response forms were provided, customers were instructed to notify hospital personnel if product was further distributed, and remove recalled products from circulation. Replacement parts were made available, customers may contact Audrey Daenzer, Field Action Specialist, Regulatory Compliance Biomet, Inc., audrev.daenzer@biomet.com, or 574-372-1570 Monday- Friday 8 AM to 5 PM.

Recalling firm

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

Distribution

Distribution pattern: Distributed in the states of VA and TX and the country of Japan.

Timeline

Recall initiated: 2015-01-09
Posted by FDA: 2015-02-17
Terminated: 2015-10-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133700. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.