Z-0812-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 30, 2022
- Initiation Date
- February 14, 2022
- Termination Date
- September 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2594
Product Description
BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill Bit, Item # 829032170, 3.5X140MM DRILL], [ALPS Tap, Item # 824150170, 3.5X140MM CORTICAL TAP], [ALPS Guide Pin, Item # 829516150, 1.6X150MM BAYONET TIP GUIDE PIN], [ALPS Guide Pin, Item # 829516151, 1.6X150MM THREADED TIP GUIDE PIN]. Instruments 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.
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 Pattern
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
Code Information
44 lots: Lot #, UDI # - [014490, (01)00887868447037(17)310608(10)014490], [014500, (01)00887868447068(17)310608(10)014500], [014520, (01)00887868447068(17)310610(10)014520], [084850, (01)00887868447006(17)310621(10)084850], [084860, (01)00887868447006(17)310623(10)084860], [084870, (01)00887868447006(17)310623(10)084870], [084880, (01)00887868447006(17)310624(10)084880], [102920, (01)00887868447006(17)310630(10)102920], [102930, (01)00887868447006(17)310716(10)102930], [102940, (01)00887868447006(17)310729(10)102940], [102950, (01)00887868447006(17)310729(10)102950], [102960, (01)00887868447006(17)310728(10)102960], [103120, (01)00887868447006(17)310728(10)103120], [119750, (01)00887868446054(17)310624(10)119750], [119760, (01)00887868446054(17)310624(10)119760], [120800, (01)00887868446054(17)310630(10)120800], [120810, (01)00887868446054(17)310713(10)120810], [204700, (01)00887868447006(17)310714(10)204700], [205750, (01)00887868447006(17)310714(10)205750], [331580, (01)00887868446054(17)310803(10)331580], [331590, (01)00887868446054(17)310723(10)331590], [331600, (01)00887868446054(17)310726(10)331600], [386440, (01)00887868447105(17)310809(10)386440], [391450, (01)00887868446054(17)310816(10)391450], [391470, (01)00887868447068(17)310811(10)391470], [391660, (01)00887868447068(17)310811(10)391660], [391670, (01)00887868447075(17)310811(10)391670], [416500, (01)00887868446054(17)310817(10)416500], [416510, (01)00887868446054(17)310817(10)416510], [416520, (01)00887868446054(17)310819(10)416520], [416640, (01)00887868446054(17)310823(10)416640], [492660, (01)00887868447006(17)310722(10)492660], [534680, (01)00887868446948(17)310713(10)534680], [534690, (01)00887868446948(17)310713(10)534690], [534700, (01)00887868446948(17)310812(10)534700], [610840, (01)00887868446948(17)310915(10)610840], [806490, (01)00887868447075(17)310528(10)806490], [820340, (01)00887868447006(17)310618(10)820340], [834950, (01)00887868446733(17)311101(10)834950], [836360, (01)00887868446948(17)310119(10)836360], [896640, (01)00887868446733(17)311101(10)896640], [896660, (01)00887868446733(17)311027(10)896660], [939270, (01)00887868447068(17)310601(10)939270], [964360, (01)00887868447068(17)310603(10)964360]