Z-0939-2018Class II

Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17)...

Name: Z-0939-2018 Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17)...
Creator: Zimmer Biomet, Inc.
Published: 2018-01-03
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-01-03 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01)... on 2018-01-03. FDA classified it as Class II and gives the reason as "Two lots of hip implants are mislabeled". 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-0939-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-03
Posted: 2018-03-09
Terminated: 2019-04-11
Recalling firm: Zimmer GmbH
Product: Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Two lots of hip implants are mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: DISTRIBUTORS: 1. Review this notification and notify affected team members of the contents. 2. Immediately locate and quarantine affected product. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to [email protected] within three (3) days. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to [email protected] RISK MANAGERS: 1. Review this notification and notify affected personnel of the contents. 2. Quarantine all affected product. Your sales representative will remove the affected product from your facility. 3. Complete Certificate of Acknowledgement and send to [email protected].
Quantity in commerce: 24
Distribution: Distributed in 2 US states: LA and NY. Distributed in Canada, China, Japan, and Switzerland.
Product codes and lots: Part Numbers: 1. 00-7864-013-00, Lot: 63703649; 2. 00-7864-013-20, Lot: 63703681

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0939-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0939-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09

Product code LPH

K051491Class IITrabecular Metal Primary Hip ProsthesisZimmer, Inc. / cleared 2005-06-30

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)