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

FDA device recall Z-1130-2014 · posted 2014-03-04 · Terminated

Recall details

Recalling firm

Djo Surgical

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

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

LPH

Quantity affected

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.

Date initiated

2014-02-07

Date posted

2014-03-04

Date terminated

2014-10-01

Location

Austin, TX

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