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Class 2 Device Recall Moore & Thompson Hip Stems |
 |
| Date Initiated by Firm |
July 22, 2014 |
| Date Posted |
August 26, 2014 |
| Recall Status1 |
Terminated 3 on September 15, 2015 |
| Recall Number |
Z-2551-2014 |
| Recall Event ID |
68818 |
| Product Classification |
Prosthesis, hip, femoral component, cemented, metal - Product Code JDG
|
| Product |
Moore & Thompson Hip Stems:
FNSTRD HIP 38HDX127ST
FNSTRD HIP 40HDX127ST
FNSTRD HIP 41HDX127ST
FNSTRD HIP 42HDX127ST
FNSTRD HIP 43HDX127ST
FNSTRD HIP 44HDX127ST
FNSTRD HIP 45HDX140ST
FNSTRD HIP 46HDX140ST
FNSTRD HIP 47HDX140ST
FNSTRD HIP 48HDX140ST
FNSTRD HIP 49HDX140ST
FNSTRD HIP 50HDX152ST
FNSTRD HIP 51HDX152ST
FNSTRD HIP 52HDX152ST
FNSTRD HIP 53HDX152ST
FNSTRD HIP 54HDX152ST
FNSTRD HIP 55HDX152ST
FNSTRD HIP 57HDX152ST
FNSTRD HIP 60HDX152ST
FNSTRD HIP 63HDX152ST
FNSTRD HIP 38HDX140ST
FNSTRD HIP 40HDX140ST
FNSTRD HIP 41HDX140ST
FNSTRD HIP 42HDX140ST
FNSTRD HIP 43HDX140ST
FNSTRD HIP 44HDX140ST
FNSTRD HIP 45HDX152ST
FNSTRD HIP 46HDX152ST
FNSTRD HIP 47HDX152ST
FNSTRD HIP 48HDX152ST
FNSTRD HIP 49HDX152ST
FNSTRD HIP 50HDX152ST
FNSTRD HIP 51HDX152ST
HIP PROS 38HDX105ST
HIP PROS 40HDX105ST
HIP PROS 41HDX105ST
HIP PROS 42HDX105ST
HIP PROS 43HDX105ST
HIP PROS 44HDX105ST
HIP PROS 45HDX105ST
HIP PROS 46HDX105ST
HIP PROS 47HDX105ST
HIP PROS 48HDX105ST
HIP PROS 49HDX105ST
HIP PROS 50HDX105ST
HIP PROS 51HDX105ST
HIP PROS 52HDX105ST
HIP PROS 53HDX105ST
HIP PROS 54HDX105ST
HIP PROS 55HDX105ST
HIP PROS 57HDX105ST
HIP PROS 60HDX105ST
HIP PROS 63HDX105ST
FNSTRD HIP 38HDX165ST
FNSTRD HIP 40DX165ST
FNSTRD HIP 41HDX165ST
FNSTRD HIP 42HDX165ST
FNSTRD HIP 43HDX165ST
FNSTRD HIP 44HDX165ST
FNSTRD HIP 45HDX165ST
FNSTRD HIP 46HDX165ST
FNSTRD HIP 47HDX165ST
FNSTRD HIP 48HDX165ST
FNSTRD HIP 49HDX165ST
FNSTRD HIP 50HDX191ST
FNSTRD HIP 51HDX191ST
FNSTRD HIP 52HDX191ST
FNSTRD HIP 53HDX191ST
FNSTRD HIP 54HDX191ST
FNSTRD HIP 55HDX191ST
FNSTRD HIP 57HDX191ST
FNSTRD HIP 60HDX191ST
FNSTRD HIP 63HDX191ST
FNSTRD HIP 38HDX165ST
FNSTRD HIP 41HDX165ST
FNSTRD HIP 43HDX165ST
FNSTRD HIP 44HDX165ST
FNSTRD HIP 46HDX165ST
FNSTRD HIP 48HDX165ST
FNSTRD HIP 49HDX165ST
FNSTRD HIP 51HDX165ST
HIP PROS 38HDX127ST
HIP PROS 40HDX127ST
HIP PROS 41HDX127ST
HIP PROS 42HDX127ST
HIP PROS 43HDX127ST
HIP PROS 44HDX127ST
HIP PROS 45HDX140ST
HIP PROS 46HDX140ST
HIP PROS 47HDX140ST
HIP PROS 48HDX140ST
HIP PROS 49HDX140ST
HIP PROS 50HDX152ST
HIP PROS 51HDX152ST
HIP PROS 52HDX152ST
HIP PROS 53HDX152ST
HIP PROS 54HDX152ST
HIP PROS 55HDX152ST
HIP PROS 57HDX152ST
HIP PROS 60HDX152ST
HIP PROS 63HDX152ST
HIP PROS 38HDX165ST
HIP PROS 40HDX165ST
HIP PROS 41HDX165ST
HIP PROS 42HDX165ST
HIP PROS 43HDX165ST
HIP PROS 44HDX165ST
HIP PROS 45HDX165ST
HIP PROS 46HDX165ST
HIP PROS 47HDX165ST
HIP PROS 48HDX165ST
HIP PROS 49HDX165ST
HIP PROS 50HDX191ST
HIP PROS 51HDX191ST
HIP PROS 52HDX191ST
HIP PROS 53HDX191ST
HIP PROS 54HDX191ST
HIP PROS 55HDX191ST
HIP PROS 57HDX191ST
HIP PROS 60HDX191ST
HIP PROS 63HDX191ST
|
| Code Information |
Item Numbers:00400500038, 00400500040, 00400500041, 00400500042, 00400500043, 00400500044, 00400500045, 00400500046, 00400500047, 00400500048, 00400500049, 00400500050, 00400500051, 00400500052, 00400500053, 00400500054, 00400500055, 00400500057, 00400500060, 00400500063, 00400600038, 00400600040, 00400600041, 00400600042, 00400600043, 00400600044, 00400600045, 00400600046, 00400600047, 00400600048, 00400600049, 00400600050, 00400600051, 00401000038, 00401000040, 00401000041, 00401000042, 00401000043, 00401000044, 00401000045, 00401000046, 00401000047, 00401000048, 00401000049, 00401000050, 00401000051, 00401000052, 00401000053, 00401000054, 00401000055,, 00401000057, 00401000060, 00401000063, 00402200038, 00402200040, 00402200041, 00402200042, 00402200043, 00402200044, 00402200045, 00402200046, 00402200047, 00402200048, 00402200049, 00402200050, 00402200051, 00402200052, 00402200053, 00402200054, 00402200055, 00402200057, 00402200060, 00402200063, 00402300038, 00402300041, 00402300043, 00402300044, 00402300046, 00402300048, 00402300049, 00402300051, 30400500038, 30400500040, 30400500041, 30400500042, 30400500043, 30400500044, 30400500045, 30400500046, 30400500047, 30400500048, 30400500049, 30400500050, 30400500051, 30400500052, 30400500053, 30400500054, 30400500055, 30400500057, 30400500060, 30400500063, 30402200038, 30402200040, 30402200041, 30402200042, 30402200043, 30402200044, 30402200045, 30402200046, 30402200047, 30402200048, 30402200049, 30402200050, 30402200051, 30402200052, 30402200053, 30402200054, 30402200055, 30402200057, 30402200060, 30402200063 EXPIRATION DATE PRIOR TO 2024-07 |
Recalling Firm/
Manufacturer |
Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
|
| For Additional Information Contact |
800-613-6131
|
Manufacturer Reason
for Recall |
Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from
each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
|
FDA Determined
Cause 2 |
Package design/selection |
| Action |
Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice. |
| Quantity in Commerce |
972,125 units |
| Distribution |
Worldwide Distribution. |
| Total Product Life Cycle |
TPLC Device Report
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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.
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