| Date Initiated by Firm |
September 03, 2015 |
| Create Date |
October 15, 2015 |
| Recall Status1 |
Terminated 3 on October 04, 2016 |
| Recall Number |
Z-0125-2016 |
| Recall Event ID |
72133 |
| Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
| Product |
Inserter for Titanium Elastic Nails (TEN), orthopedic device |
| Code Information |
Part Number 359.219 lot numbers: 1095607 3301017 4826021 5422955 5718485 8006578 8017872 1121876 3325276 4911859 5455364 5718486 8007139 8018319 1641700 3382583 4911860 5455365 5718487 8007472 8114862 1806500 3410330 4969014 5485078 7505411 8008046 8214803 1811056 3430483 4971314 5492810 7565990 8008261 8326267 1811059 3493588 5042001 5496455 7601112 8009205 8424513 1813900 3504996 5066417 5507788 7619995 8009363 8476286 1904339 3524633 5066418 5525235 7670741 8009859 8541845 3005674 3619119 5090224 5545372 7675623 8012109 8608192 3005675 3626055 5090226 5555604 7727696 8012353 8608193 3009312 3659645 5106335 5569028 7774491 8012925 8768253 3020674 3706611 5123586 5611445 7810649 8013244 8973607 3025607 3797835 5123587 5611446 7845943 8014078 9275702 3051190 4321659 5162204 5611447 7874224 8014645 A8LA901 3054608 4340451 5162205 5641429 7896075 8015605 A8MA648 3065013 4389269 5162206 5641430 7979727 8015831 A8MB744 3069566 4466686 5162760 5657073 8000136 8016063 A8NA025 3084637 4470900 5181760 5657075 8002518 8016128 A8NA430 3098634 4537554 5181761 5670474 8002635 8016423 3121438 4594280 5227459 5670475 8004538 8016759 3232931 4594281 5236654 5700077 8005179 8017447 3242304 4796463 5258103 5700078 8006103 8017590 3262712 4825384 5420946 5700079 8006214 8017862 |
Recalling Firm/
Manufacturer |
Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
|
| For Additional Information Contact |
Customer Support
610-719-6500
|
Manufacturer Reason
for Recall |
potential for mechanical failures such as breakage.
|
FDA Determined
Cause 2 |
Device Design |
| Action |
Synthes sent an Urgent Notice: Medical Device Recall letter dated September 3, 2015, to all affected customers. The letter identified the product the problem and the action need to be taken by the customer.
ACTIONS REQUIRED:
We have record that your facility has received the product(s) subject to this recall. It is important to note that the removal of the product would prevent the performance of emergency surgery, thus DePuy Synthes is not requiring an immediate removal of affected product(s). DePuy Synthes has developed a replacement & recovery plan for indicated devices and replacement parts are becoming available. If you have questions on replacement timing and availability, please call DePuy Synthes at 1-800-479-6329.
If you have questions regarding the return and recovery of the part, we ask that you contact your local DePuy Synthes Sales Consultant. |
| Quantity in Commerce |
1550 |
| Distribution |
US (nationwide) distribution and one Internationally to Australia. |
| 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.
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