Z-0650-2016Class II

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

Name: Z-0650-2016 Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
Creator: Biomet, Inc.
Published: 2015-11-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-11-17 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm on 2015-11-17. FDA classified it as Class II and gives the reason as "PMMA is listed as a material on the label but the product does not contain PMMA". 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-0650-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-17
Posted: 2016-01-13
Terminated: 2016-07-05
Recalling firm: Zimmer GmbH
Product: Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: PMMA is listed as a material on the label but the product does not contain PMMA.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 21
Distribution: Worldwide distribution. US nationwide including IA, UT, MN, PA, MO, OK, IL, OH, and WA; CANADA, and NETHERLANDS
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0650-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0650-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-13

Product code LZO

K942479Class IIIntegral Co-Cr Femoral ComponentBiomet, Inc. / cleared 1994-09-20

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)