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
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling various trauma drill bits, taps, and guide pins because their packaging may not have sufficient adhesion on all sides, which could compromise the sterile barrier. A total of 2,594 units across 44 lots have been distributed worldwide, including to 28 U.S. states, Australia, Japan, and the Netherlands. If the sterile barrier is compromised, use of the product poses a risk of infection that could require surgical intervention or extension of surgery to locate another part.
The source does not specify a remedy for consumers who have received affected products.
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: 2594 Lot/code info: 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)0088786844605
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.