Biomet, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0812-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 14, 2022

Date Posted: March 30, 2022

Recall Number: Z-0812-2022

Event ID: 89701

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.

Status: Terminated

Product Quantity: 2594

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]

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

Voluntary or Mandated:

Voluntary: Firm initiated