Inserter for Titanium Elastic Nails (TEN), orthopedic device
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Synthes (USA) Products LLC
- Reason for Recall:
- potential for mechanical failures such as breakage.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Inserter for Titanium Elastic Nails (TEN), orthopedic device
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0125-2016
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