Z-2214-2010

Trabecular Metal acetabular revision system buttress augment size, 54, 00-4898-001-54, sterile, Zimmer Inc...

Name: Z-2214-2010 Trabecular Metal acetabular revision system buttress augment size, 54, 00-4898-001-54, sterile, Zimmer Inc...
Creator: Zimmer Inc.
Published: 2010-04-06
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-04-06 / Terminated / root cause: packaging

FDA source

Zimmer Inc. began a recall of Trabecular Metal acetabular revision system buttress augment size, 54, 00-4898-001-54, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that... on 2010-04-06. The reason FDA records is "The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2214-2010
Status: Terminated
Initiated: 2010-04-06
Posted: 2010-08-12
Terminated: 2011-10-21
Recalling firm: Zimmer GmbH
Product: Trabecular Metal acetabular revision system buttress augment size, 54, 00-4898-001-54, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
Root cause tag: packaging
FDA root cause: Packaging
Action: The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.
Quantity in commerce: 1972 all products
Distribution: US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland.
Product codes and lots: 60492194, 60531068, 60530835, 60724676, 60680532, 60770940, 60796676, 60904592, 61195210, 61076505, 61424513 and 61424514.

Product code LPH

K061067Class IITrabecular Metal Acetabular AugmentsZimmer Trabecular / cleared 2006-05-25

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)