BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ***Lot Numbers*** 860910, 215450, 555580, 583860, 089700, 102920, 283420, 148680, 503890, 954890, 097260, 325340, 409370, 409450, 409490, 851280, 234350, 452060, 706850, 257410, 709790, 967440, 079230, 262250, 458790, 728540, 172680, 533270, 776910, 020620, 196040, 526700, 751880, 988270, 115360, 282070, 410360, 908940, 978030, 978040, 313260, 313270, 089530, 089540, 637400, 637410, 685000, 398240, 398250, 398280, 398260, 877310, 877320, 877330, 202540, 398260R, 555580R, 398240R, 674430, 809060, 747370, 916210, 916220, 262250R, 877320R, 349570, 914620, 914630, 962810, 963780, 005670, 035060, 399640, 399660, 399670, 399680, 417040, 417060, 417070, 308170, 705200, 694850, 736560, 372280, 064920, 637410R, 186470. ***UDI Numbers*** (01)00880304551008(17)141007(10)860910, (01)00880304551008(17)141112(10)215450, (01)00880304551008(17)181231(10)555580, (01)00880304551008(17)181231(10)583860, (01)00880304551008(17)190206(10)089700, (01)00880304551008(17)190215(10)102920, (01)00880304551008(17)190319(10)283420, (01)00880304551008(17)190609(10)148680, (01)00880304551008(17)190609(10)503890, (01)00880304551008(17)190721(10)954890, (01)00880304551008(17)190731(10)097260, (01)00880304551008(17)190815(10)325340, (01)00880304551008(17)190826(10)409370, (01)00880304551008(17)190826(10)409450, (01)00880304551008(17)190826(10)409490, (01)00880304551008(17)190930(10)851280, (01)00880304551008(17)191104(10)234350, (01)00880304551008(17)191119(10)452060, (01)00880304551008(17)191223(10)706850, (01)00880304551008(17)200323(10)257410, (01)00880304551008(17)200403(10)709790, (01)00880304551008(17)200428(10)967440, (01)00880304551008(17)200507(10)079230, (01)00880304551008(17)200525(10)262250, (01)00880304551008(17)200612(10)458790, (01)00880304551008(17)200711(10)728540, (01)00880304551008(17)200824(10)172680, (01)00880304551008(17)200928(10)533270, (01)00880304551008(17)201019(10)776910, (01)00880304551008(17)201111(10)020620, (01)00880304551008(17)201201(10)196040, (01)00880304551008(17)201223(10)526700, (01)00880304551008(17)210118(10)751880, (01)00880304551008(17)210208(10)988270, (01)00880304551008(17)210217(10)115360, (01)00880304551008(17)210302(10)282070, (01)00880304551008(17)210315(10)410360, (01)00880304551008(17)210425(10)908940, (01)00880304551008(17)210427(10)978030, (01)00880304551008(17)210427(10)978040, (01)00880304551008(17)210527(10)313260, (01)00880304551008(17)210527(10)313270, (01)00880304551008(17)210801(10)089530, (01)00880304551008(17)210801(10)089540, (01)00880304551008(17)210919(10)637400, (01)00880304551008(17)210920(10)637410, (01)00880304551008(17)211123(10)685000, (01)00880304551008(17)220518(10)398240, (01)00880304551008(17)220518(10)398250, (01)00880304551008(17)220518(10)398280, (01)00880304551008(17)220527(10)398260, (01)00880304551008(17)220608(10)877310, (01)00880304551008(17)220608(10)877320, (01)00880304551008(17)220608(10)877330, (01)00880304551008(17)220630(10)202540, (01)00880304551008(17)220527(10)398260R, (01)00880304551008(17)181202(10)555580R, (01)00880304551008(17)220518(10)398240R, (01)00880304551008(17)221018(10)674430, (01)00880304551008(17)221103(10)809060, (01)00880304551008(17)230116(10)747370, (01)00880304551008(17)230201(10)916210, (01)00880304551008(17)230204(10)916220, (01)00880304551008(17)200525(10)262250R, (01)00880304551008(17)220608(10)877320R, (01)00880304551008(17)240205(10)349570, (01)00880304551008(17)240316(10)914620, (01)00880304551008(17)240317(10)914630, (01)00880304551008(17)240316(10)962810, (01)00880304551008(17)240314(10)963780, (01)00880304551008(17)240320(10)005670, (01)00880304551008(17)240323(10)035060, (01)00880304551008(17)240416(10)399640, (01)00880304551008(17)240416(10)399660, (01)00880304551008(17)240416(10)399670, (01)00880304551008(17)240416(10)399680, (01)00880304551008(17)240502(10)417040, (01)00880304551008(17)240502(10)417060, (01)00880304551008(17)240502(10)417070, (01)00880304551008(17)240819(10)308170, (01)00880304551008(17)240905(10)705200, (01)00880304551008(17)240912(10)694850, (01)00880304551008(17)240926(10)736560, (01)00880304551008(17)241024(10)372280, (01)00880304551008(17)241218(10)064920, (01)00880304551008(17)210920(10)637410R, (01)00880304551008(17)250113(10)186470
- 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:
- Biomet, Inc.
- Reason for Recall:
- Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
Product Codes/Lot Numbers:
***Lot Numbers*** 860910, 215450, 555580, 583860, 089700, 102920, 283420, 148680, 503890, 954890, 097260, 325340, 409370, 409450, 409490, 851280, 234350, 452060, 706850, 257410, 709790, 967440, 079230, 262250, 458790, 728540, 172680, 533270, 776910, 020620, 196040, 526700, 751880, 988270, 115360, 282070, 410360, 908940, 978030, 978040, 313260, 313270, 089530, 089540, 637400, 637410, 685000, 398240, 398250, 398280, 398260, 877310, 877320, 877330, 202540, 398260R, 555580R, 398240R, 674430, 809060, 747370, 916210, 916220, 262250R, 877320R, 349570, 914620, 914630, 962810, 963780, 005670, 035060, 399640, 399660, 399670, 399680, 417040, 417060, 417070, 308170, 705200, 694850, 736560, 372280, 064920, 637410R, 186470. ***UDI Numbers*** (01)00880304551008(17)141007(10)860910, (01)00880304551008(17)141112(10)215450, (01)00880304551008(17)181231(10)555580, (01)00880304551008(17)181231(10)583860, (01)00880304551008(17)190206(10)089700, (01)00880304551008(17)190215(10)102920, (01)00880304551008(17)190319(10)283420, (01)00880304551008(17)190609(10)148680, (01)00880304551008(17)190609(10)503890, (01)00880304551008(17)190721(10)954890, (01)00880304551008(17)190731(10)097260, (01)00880304551008(17)190815(10)325340, (01)00880304551008(17)190826(10)409370, (01)00880304551008(17)190826(10)409450, (01)00880304551008(17)190826(10)409490, (01)00880304551008(17)190930(10)851280, (01)00880304551008(17)191104(10)234350, (01)00880304551008(17)191119(10)452060, (01)00880304551008(17)191223(10)706850, (01)00880304551008(17)200323(10)257410, (01)00880304551008(17)200403(10)709790, (01)00880304551008(17)200428(10)967440, (01)00880304551008(17)200507(10)079230, (01)00880304551008(17)200525(10)262250, (01)00880304551008(17)200612(10)458790, (01)00880304551008(17)200711(10)728540, (01)00880304551008(17)200824(10)172680, (01)00880304551008(17)200928(10)533270, (01)00880304551008(17)201019(10)776910, (01)00880304551008(17)201111(10)020620, (01)00880304551008(17)201201(10)196040, (01)00880304551008(17)201223(10)526700, (01)00880304551008(17)210118(10)751880, (01)00880304551008(17)210208(10)988270, (01)00880304551008(17)210217(10)115360, (01)00880304551008(17)210302(10)282070, (01)00880304551008(17)210315(10)410360, (01)00880304551008(17)210425(10)908940, (01)00880304551008(17)210427(10)978030, (01)00880304551008(17)210427(10)978040, (01)00880304551008(17)210527(10)313260, (01)00880304551008(17)210527(10)313270, (01)00880304551008(17)210801(10)089530, (01)00880304551008(17)210801(10)089540, (01)00880304551008(17)210919(10)637400, (01)00880304551008(17)210920(10)637410, (01)00880304551008(17)211123(10)685000, (01)00880304551008(17)220518(10)398240, (01)00880304551008(17)220518(10)398250, (01)00880304551008(17)220518(10)398280, (01)00880304551008(17)220527(10)398260, (01)00880304551008(17)220608(10)877310, (01)00880304551008(17)220608(10)877320, (01)00880304551008(17)220608(10)877330, (01)00880304551008(17)220630(10)202540, (01)00880304551008(17)220527(10)398260R, (01)00880304551008(17)181202(10)555580R, (01)00880304551008(17)220518(10)398240R, (01)00880304551008(17)221018(10)674430, (01)00880304551008(17)221103(10)809060, (01)00880304551008(17)230116(10)747370, (01)00880304551008(17)230201(10)916210, (01)00880304551008(17)230204(10)916220, (01)00880304551008(17)200525(10)262250R, (01)00880304551008(17)220608(10)877320R, (01)00880304551008(17)240205(10)349570, (01)00880304551008(17)240316(10)914620, (01)00880304551008(17)240317(10)914630, (01)00880304551008(17)240316(10)962810, (01)00880304551008(17)240314(10)963780, (01)00880304551008(17)240320(10)005670, (01)00880304551008(17)240323(10)035060, (01)00880304551008(17)240416(10)399640, (01)00880304551008(17)240416(10)399660, (01)00880304551008(17)240416(10)399670, (01)00880304551008(17)240416(10)399680, (01)00880304551008(17)240502(10)417040, (01)00880304551008(17)240502(10)417060, (01)00880304551008(17)240502(10)417070, (01)00880304551008(17)240819(10)308170, (01)00880304551008(17)240905(10)705200, (01)00880304551008(17)240912(10)694850, (01)00880304551008(17)240926(10)736560, (01)00880304551008(17)241024(10)372280, (01)00880304551008(17)241218(10)064920, (01)00880304551008(17)210920(10)637410R, (01)00880304551008(17)250113(10)186470
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1660-2020
Related Recalls
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.