FDA Device recall Z-0812-2022
BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160…
- FDA Device
- Class II
- terminated
- Published 2022-03-30
On 2022-03-30 the FDA classified a Class II recall of BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160… by Biomet, citing 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 surgi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0812-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-14 |
| Published | 2022-03-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomet |
| Distribution | 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 |
Product
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
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.
Identifiers
| code_info | 44 lots: Lot #, UDI # - [014490, (01)00887868447037(17)310608(10)014490], [014500, (01)00887868447068(17)310608(10)01…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], [33158 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0812-2022%22
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