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FMP X-alt Acetabular Liner recallZ-1130-2014 · Djo Surgical · initiated Feb 7, 2014

Class II Terminated All recalls posted in March 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Djo Surgical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-1130-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Feb 7, 2014
Posted by the FDA
Mar 4, 2014
Recalling firm
Djo Surgical
Quantity
10 units of Model/Catalog Number 931-28-248 Lot/Serial Number(s) 685F1034 labeled asModel/Catalog Number 932-36-252, Lot# 728F1089
Product code
LPH
FDA submissions
K072154
Distribution
Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.

Product description

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

25 devices cleared under K072154 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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