Z-0415-2013Class II

Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere...

Name: Z-0415-2013 Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere...
Creator: Biomet, Inc.
Published: 2012-10-04
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-10-04 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell... on 2012-10-04. FDA classified it as Class II and gives the reason as "The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0415-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-04
Posted: 2012-11-21
Terminated: 2013-03-18
Recalling firm: Zimmer GmbH
Product: Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip replacement . The device is intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered
Product code: KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Reason for recall: The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: BIOMET called distributors who received the affected product to return it to Biomet with follow-up Urgent Recall Notices sent via E-mail October 22, 2012.. The notice included the identity of the recalled device, reason for the recall, and directions to complete the FAX back form and return it to 574-372-1683. Product is to be returned to Return Goods, Recalls, Biomet, Inc. 56 East Bell Drive, Warsaw, IN 46580. Questions related to the recall should be directed to Field Action Coordinator (574) 372-1570, Monday through Friday. 8 a.m. to 5 p.m. For questions regarding this recall call 574-267-6639, ext 1676.
Quantity in commerce: 16 (5 USA)
Distribution: Nationwide Distribution including CA, IN, NC, OH, and UT.
Product codes and lots: Part 11-106054 Lot 528310

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0415-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0415-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21

Product code KWA

K050124Class IIIPorous Coated Acetabular ComponentsBiomet, Inc. / cleared 2005-10-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)