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 o
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling JUGGERLOC SLOTTED REAMER implants in sizes 5MM, 6MM, 7MM, and 8MM due to packaging that may not have sufficient adhesion on all sides, which could compromise the sterile barrier. The recall affects 702 devices across 29 lots distributed worldwide in 28 U.S. states (including California, Texas, New York, and Florida), as well as Australia, Japan, and the Netherlands.
Use of the affected devices poses a risk of infection that could require surgical intervention or extension of surgery to locate an alternative part. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MS, NC, NE, NM, NY, OH, OK, OR, SC, TX, UT, WA, WY), Australia, Japan, and Netherlands Quantity: 702 Lot/code info: 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]
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.