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U.S. Department of Health and Human Services

Class 2 Device Recall FMP Xalt Acetabular Liner

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  Class 2 Device Recall FMP Xalt Acetabular Liner see related information
Date Initiated by Firm February 07, 2014
Date Posted March 04, 2014
Recall Status1 Terminated 3 on October 01, 2014
Recall Number Z-1130-2014
Recall Event ID 67468
510(K)Number K072154  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
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.
Code Information 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
Recalling Firm/
Manufacturer		 Djo Surgical
9800 Metric Blvd
Austin TX 78758-5445
Manufacturer 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
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = ENCORE MEDICAL, L.P.
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