Z-1130-2014Class II

FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is...

Name: Z-1130-2014 FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is...
Creator: Djo Surgical
Published: 2014-02-07
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2014-02-07 / Terminated / root cause: packaging

FDA source

Djo Surgical began a recall of FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the... on 2014-02-07. FDA classified it as Class II and gives the reason as "Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being...". 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-1130-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-07
Posted: 2014-03-04
Terminated: 2014-10-01
Recalling firm: Encore Medical, LP
Product: FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. The units labeled as Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the outside and containing Model/Catalog Number 932-36-252, Lot# 728F1089 on the inside (1
Root cause tag: packaging
FDA root cause: Packaging process control
Action: DJO Global sent an Urgent Field Safety Notice dated February 7, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. All 10 devices with the outer label of 931-28-248, Lot#685F1034 were found in-house and were quarantined. The agencies who have the affected product (devices labeled as 932-36-252, Lot# 728F1089 containing 931-28-248, Lot#685F1034) were contacted to quarantine their devices. Of the affected devices, 2 of the lot of 10 have already been returned via product complaint. Customers were instructed to pass on the notice to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. Customers were instructed to place a replacement order and receive an RMA number to return all affected devices.. Customers with questions were instructed to call 512-834-6255.
Quantity in commerce: 10 units of Model/Catalog Number 931-28-248 Lot/Serial Number(s) 685F1034 labeled asModel/Catalog Number 932-36-252, Lot# 728F1089
Distribution: Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.
Product codes and lots: Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 (an MP5 Non-Hooded, Neutral Liner) were mistakenly packaged/labeled as Model/Catalog Number 932-36-252, Lot# 728F1089 (an MP7 10-degree Hooded Liner) and vice-versa

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1130-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1130-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04

Product code LPH

K072154Class IIFoundation (Fmp) Porous Coated Spiked Acetabular SystemEncore Medical L.P. / cleared 2007-12-14

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)