BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 29 lots: Lot Number, UDI Number - [061400, (01)00887868465758(17)310630(10)061400], [061410, (01)00887868465758(17)310723(10)061410], [089370, (01)00887868465758(17)310726(10)089370], [260770, (01)00880304857261(17)310917(10)260770], [503410, (01)00880304857285(17)311011(10)503410], [503420, (01)00880304857261(17)310924(10)503420], [503430, (01)00880304857285(17)311011(10)503430], [503450, (01)00880304857261(17)310924(10)503450], [503460, (01)00880304857285(17)311011(10)503460], [503610, (01)00880304857285(17)310924(10)503610], [539370, (01)00880304857285(17)311105(10)539370], [549910, (01)00887868465758(17)310603(10)549910], [577830, (01)00880304857292(17)310917(10)577830], [577840, (01)00880304857292(17)310922(10)577840], [577860, (01)00880304857292(17)310917(10)577860], [637200, (01)00880304857285(17)311027(10)637200], [796600, (01)00880304857285(17)311105(10)796600], [796610, (01)00880304857261(17)311027(10)796610], [886120, (01)00880304857285(17)310805(10)886120], [886200, (01)00880304857285(17)310805(10)886200], [886210, (01)00880304857285(17)310727(10)886210], [886220, (01)00880304857285(17)310726(10)886220], [886230, (01)00880304857285(17)310813(10)886230], [886240, (01)00880304857285(17)310805(10)886240], [886260, (01)00880304857285(17)310922(10)886260], [886270, (01)00880304857285(17)310922(10)886270], [886290, (01)00880304857285(17)310917(10)886290], [954740, (01)00880304857285(17)310922(10)954740], [954760, (01)00880304857285(17)310922(10)954760]
- 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:
- Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
Product Codes/Lot Numbers:
29 lots: Lot Number, UDI Number - [061400, (01)00887868465758(17)310630(10)061400], [061410, (01)00887868465758(17)310723(10)061410], [089370, (01)00887868465758(17)310726(10)089370], [260770, (01)00880304857261(17)310917(10)260770], [503410, (01)00880304857285(17)311011(10)503410], [503420, (01)00880304857261(17)310924(10)503420], [503430, (01)00880304857285(17)311011(10)503430], [503450, (01)00880304857261(17)310924(10)503450], [503460, (01)00880304857285(17)311011(10)503460], [503610, (01)00880304857285(17)310924(10)503610], [539370, (01)00880304857285(17)311105(10)539370], [549910, (01)00887868465758(17)310603(10)549910], [577830, (01)00880304857292(17)310917(10)577830], [577840, (01)00880304857292(17)310922(10)577840], [577860, (01)00880304857292(17)310917(10)577860], [637200, (01)00880304857285(17)311027(10)637200], [796600, (01)00880304857285(17)311105(10)796600], [796610, (01)00880304857261(17)311027(10)796610], [886120, (01)00880304857285(17)310805(10)886120], [886200, (01)00880304857285(17)310805(10)886200], [886210, (01)00880304857285(17)310727(10)886210], [886220, (01)00880304857285(17)310726(10)886220], [886230, (01)00880304857285(17)310813(10)886230], [886240, (01)00880304857285(17)310805(10)886240], [886260, (01)00880304857285(17)310922(10)886260], [886270, (01)00880304857285(17)310922(10)886270], [886290, (01)00880304857285(17)310917(10)886290], [954740, (01)00880304857285(17)310922(10)954740], [954760, (01)00880304857285(17)310922(10)954760]
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0809-2022
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.