Z-3014-2011

Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip...

Name: Z-3014-2011 Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip...
Creator: Aesculap Inc
Published: 2011-07-19
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2011-07-19 / Terminated / root cause: manufacturing process

FDA source

Aesculap Inc began a recall of Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems. Aesculap AG. Intended to replace a hip joint on 2011-07-19. The reason FDA records is "Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3014-2011
Status: Terminated
Initiated: 2011-07-19
Posted: 2011-08-12
Terminated: 2013-03-19
Recalling firm: Aesculap Inc
Product: Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems. Aesculap AG. Intended to replace a hip joint
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter.
Root cause tag: manufacturing process
FDA root cause: Unknown/Undetermined by firm
Action: AESCULAP Implant Systems sent an "Important Recall Notification" letter dated to all affected customers. The informed customers of a complaint received where fractured CoCR adapter was found and to return any affected product to the firm. The reason for the fracture is currently under investigation. While the firm is trying to determine the root cause of the fracture, they will be offering the Metha non-modular short hip implants to their customers. Customers are asked to return an Inventory Sheet to AESCULAP. For additional information on this recall call (610) 984-9239 or (610) 984-9300.
Quantity in commerce: 149
Distribution: Nationwide (USA) Distribution including the states of AL, FL, GA, MD, NM, NY, OK, and TN.
Product codes and lots: Part Numbers: NC077K, NC078K, NC079K, NC087K, NC088K, NC089K, NC097K, NC098K, and NC099K) Lot Numbers: All distributed lot numbers.

Product code LZO

K071916Class IIMetha Hip SystemAesculap Implant Systems, Inc. / cleared 2008-06-02

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)