Z-1954-2016Class II

Rev. Shell Liner 0D 28X48 00700504828 Rev. Shell Liner 10D 28X50 00701005028 Rev. Shell Liner 10D 28X52...

Name: Z-1954-2016 Rev. Shell Liner 0D 28X48 00700504828 Rev. Shell Liner 10D 28X50 00701005028 Rev. Shell Liner 10D 28X52...
Creator: Zimmer Trabecular Metal Technology, Inc.
Published: 2016-04-15
License: https://open.fda.gov/license/

Zimmer Trabecular Metal Technology, Inc. / initiated 2016-04-15 / Terminated / root cause: packaging

FDA source

Zimmer Trabecular Metal Technology, Inc. began a recall of REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV... on 2016-04-15. FDA classified it as Class II and gives the reason as "Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to...". 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-1954-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Posted: 2016-06-10
Terminated: 2017-11-29
Recalling firm: Zimmer Trabecular Metal Technology, Inc.
Product: Rev. Shell Liner 0D 28X48 00700504828 Rev. Shell Liner 10D 28X50 00701005028 Rev. Shell Liner 10D 28X52 00701005228 Rev. Shell Liner 10D 28X54 00701005428 Rev. Shell Liner 10D 28X56 00701005628 Rev. Shell Liner 10D 28X58 00701005828 Rev. Shell Liner 10D 28X60 00701006028 Rev. Shell Liner 10D 28X62 00701006228 Rev. Shell Line 10D 28X66 00701006628 Rev. Shell Liner 20D 28X48 00702004828 Rev. Shell Liner 20D 28X50 00702005028 Rev. Shell Liner 20D 28X52 00702005228 Rev. Shell Liner 20D 28X54 00702005428 Rev. Shell Liner 20D 28X56 00702005628 Rev. Shell Liner 20D 28X60 00702006028 Rev. Shell Liner 20D 28X62 00702006228 Rev. Shell Liner 20D 28X66 00702006628
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.
Root cause tag: packaging
FDA root cause: Unknown/Undetermined by firm
Action: Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/2016.
Quantity in commerce: 19,884 total
Distribution: Nationwide and Foreign.
Product codes and lots: 00700504828 REV. SHELL LINER 0D 28X48 62192382 61924517 61979224 62102328 00701005028 REV. SHELL LINER 10D 28X50 61787378 61979209 62165315 62188095 00701005228 REV. SHELL LINER 10D 28X52 61979218 00701005428 REV. SHELL LINER 10D 28X54 61787382 62077039 00701005628 REV. SHELL LINER 10D 28X56 61799041 61976886 62165323 62188094 00701005828 REV. SHELL LINER 10D 28X58 61886620 62103434 00701006028 REV. SHELL LINER 10D 28X60 61979220 61979221 62077046 00701006228 REV. SHELL LINER 10D 28X62 61986244 62101503 62192380 00701006628 REV. SHELL LINE 10D 28X66 61787381 61979212 62042739 62042740 00702004828 REV. SHELL LINER 20D 28X48 61987076 00702005028 REV. SHELL LINER 20D 28X50 61987075 00702005228 REV. SHELL LINER 20D 28X52 62102429 00702005428 REV. SHELL LINER 20D 28X54 62103435 00702005628 REV. SHELL LINER 20D 28X56 61964049 62029515 62077034 62102329 00702006028 REV. SHELL LINER 20D 28X60 61787385 61853155 00702006228 REV. SHELL LINER 20D 28X62 61915568 61979214 62102867 00702006628 REV. SHELL LINER 20D 28X66 61787383 61787384 62102865

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1954-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1950-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10
Z-1951-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10
Z-1952-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10
Z-1953-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10
Z-1954-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10
Z-1955-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10

Product code JDI

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)