Z-2551-2014Class II

Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP...

Name: Z-2551-2014 Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP...
Creator: Zimmer, Inc.
Published: 2014-07-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-07-22 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST... on 2014-07-22. FDA classified it as Class II and gives the reason as "Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six...". 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-2551-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-22
Posted: 2014-08-26
Terminated: 2015-09-15
Recalling firm: Zimmer GmbH
Product: Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP 46HDX140ST FNSTRD HIP 47HDX140ST FNSTRD HIP 48HDX140ST FNSTRD HIP 49HDX140ST FNSTRD HIP 50HDX152ST FNSTRD HIP 51HDX152ST FNSTRD HIP 52HDX152ST FNSTRD HIP 53HDX152ST FNSTRD HIP 54HDX152ST FNSTRD HIP 55HDX152ST FNSTRD HIP 57HDX152ST FNSTRD HIP 60HDX152ST FNSTRD HIP 63HDX152ST FNSTRD HIP 38HDX140ST FNSTRD HIP 40HDX140ST FNSTRD HIP 41HDX140ST FNSTRD HIP 42HDX140ST FNSTRD HIP 43HDX140ST FNSTRD HIP 44HDX140ST FNSTRD HIP 45HDX152ST FNSTRD HIP 46HDX152ST FNSTRD HIP 47HDX152ST FNSTRD HIP 48HDX152ST FNSTRD HIP 49HDX152ST FNSTRD HIP 50HDX152ST FNSTRD HIP 51HDX152ST HIP PROS 38HDX105ST HIP PROS 40HDX105ST HIP PROS 41HDX105ST HIP PROS 42HDX105ST HIP PROS 43HDX105ST HIP PROS 44HDX105ST HIP PROS 45HDX105ST HIP PROS 46HDX105ST HIP PROS 47HDX105ST HIP PROS 48HDX105ST HIP PROS 49HDX105ST HIP PROS 50HDX105ST HIP PROS 51HDX105ST HIP PROS 52HDX105ST HIP PROS 53HDX105ST HIP PROS 54HDX105ST HIP PROS 55HDX105ST HIP PROS 57HDX105ST HIP PROS 60HDX105ST HIP PROS 63HDX105ST FNSTRD HIP 38HDX165ST FNSTRD HIP 40DX165ST FNSTRD HIP 41HDX165ST FNSTRD HIP 42HDX165ST FNSTRD HIP 43HDX165ST FNSTRD HIP 44HDX165ST FNSTRD HIP 45HDX165ST FNSTRD HIP 46HDX165ST FNSTRD HIP 47HDX165ST FNSTRD HIP 48HDX165ST FNSTRD HIP 49HDX165ST FNSTRD HIP 50HDX191ST FNSTRD HIP 51HDX191ST FNSTRD HIP 52HDX191ST FNSTRD HIP 53HDX191ST FNSTRD HIP 54HDX191ST FNSTRD HIP 55HDX191ST FNSTRD HIP 57HDX191ST FNSTRD HIP 60HDX191ST FNSTRD HIP 63HDX191ST FNSTRD HIP 38HDX165ST FNSTRD HIP 41HDX165ST FNSTRD HIP 43HDX165ST FNSTRD HIP 44HDX165ST FNSTRD HIP 46HDX165ST FNSTRD HIP 48HDX165ST FNSTRD HIP 49HDX165ST FNSTRD HIP 51HDX165ST HIP PROS 38HDX127ST HIP PROS 40HDX127ST HIP PROS 41HDX127ST HIP PROS 42HDX127ST HIP PROS 43HDX127ST HIP PROS 44HDX127ST HIP PROS 45HDX140ST HIP PROS 46HDX140ST HIP PROS 47HDX140ST HIP PROS 48HDX140ST HIP PROS 49HDX140ST HIP PROS 50HDX152ST HIP PROS 51HDX152ST HIP PROS 52HDX152ST HIP PROS 53HDX152ST HIP PROS 54HDX152ST HIP PROS 55HDX152ST HIP PROS 57HDX152ST HIP PROS 60HDX152ST HIP PROS 63HDX152ST HIP PROS 38HDX165ST HIP PROS 40HDX165ST HIP PROS 41HDX165ST HIP PROS 42HDX165ST HIP PROS 43HDX165ST HIP PROS 44HDX165ST HIP PROS 45HDX165ST HIP PROS 46HDX165ST HIP PROS 47HDX165ST HIP PROS 48HDX165ST HIP PROS 49HDX165ST HIP PROS 50HDX191ST HIP PROS 51HDX191ST HIP PROS 52HDX191ST HIP PROS 53HDX191ST HIP PROS 54HDX191ST HIP PROS 55HDX191ST HIP PROS 57HDX191ST HIP PROS 60HDX191ST HIP PROS 63HDX191ST
Product code: JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Reason for recall: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.
Quantity in commerce: 972,125 units
Distribution: Worldwide Distribution.
Product codes and lots: Item Numbers:00400500038, 00400500040, 00400500041, 00400500042, 00400500043, 00400500044, 00400500045, 00400500046, 00400500047, 00400500048, 00400500049, 00400500050, 00400500051, 00400500052, 00400500053, 00400500054, 00400500055, 00400500057, 00400500060, 00400500063, 00400600038, 00400600040, 00400600041, 00400600042, 00400600043, 00400600044, 00400600045, 00400600046, 00400600047, 00400600048, 00400600049, 00400600050, 00400600051, 00401000038, 00401000040, 00401000041, 00401000042, 00401000043, 00401000044, 00401000045, 00401000046, 00401000047, 00401000048, 00401000049, 00401000050, 00401000051, 00401000052, 00401000053, 00401000054, 00401000055,, 00401000057, 00401000060, 00401000063, 00402200038, 00402200040, 00402200041, 00402200042, 00402200043, 00402200044, 00402200045, 00402200046, 00402200047, 00402200048, 00402200049, 00402200050, 00402200051, 00402200052, 00402200053, 00402200054, 00402200055, 00402200057, 00402200060, 00402200063, 00402300038, 00402300041, 00402300043, 00402300044, 00402300046, 00402300048, 00402300049, 00402300051, 30400500038, 30400500040, 30400500041, 30400500042, 30400500043, 30400500044, 30400500045, 30400500046, 30400500047, 30400500048, 30400500049, 30400500050, 30400500051, 30400500052, 30400500053, 30400500054, 30400500055, 30400500057, 30400500060, 30400500063, 30402200038, 30402200040, 30402200041, 30402200042, 30402200043, 30402200044, 30402200045, 30402200046, 30402200047, 30402200048, 30402200049, 30402200050, 30402200051, 30402200052, 30402200053, 30402200054, 30402200055, 30402200057, 30402200060, 30402200063 EXPIRATION DATE PRIOR TO 2024-07

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2551-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2546-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2547-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2548-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2549-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2550-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2551-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2552-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26

Product code JDG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)