Z-1046-2016Class II

M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093

Name: Z-1046-2016 M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
Creator: Zimmer Biomet, Inc.
Published: 2016-02-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-02-11 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093 on 2016-02-11. FDA classified it as Class II and gives the reason as "Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was...". 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-1046-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-11
Posted: 2016-03-04
Terminated: 2016-12-01
Recalling firm: Zimmer GmbH
Product: M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Zimmer, Inc. initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. Electronic notices were e-mailed to distributors, and letters were mailed via certified mail on 02/11/2016 to distributors and hospitals. A field complaint investigation confirmed that this single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended Offset, and the device is an extended offset stem. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: Assisting the Zimmer Biomet sales representative with the quarantine of the product and completion and return of the Acknowledgement Form. Customers are asked to complete the Certificate of Acknowledgement Form and return to [email protected]. Customers with have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.
Quantity in commerce: 9 units
Distribution: Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.
Product codes and lots: Item: 00-7711-012-20, Lot: 62937093

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1046-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1046-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-04

Product code LPH

K032726Class IIZimmer M/l Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. / cleared 2003-10-22

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)