ClearanceBrief
Recall Z-0812-2022 ยท JDR Staple, Fixation, Bone

Biomet, Inc.

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 # 82

DateFeb 14, 2022
StatusTerminated
ReasonPackaging 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.
Root causeUnder Investigation by firm
ActionA recall notification was sent via courier 24 Feb 2022 to distributors, surgeons, and hospital risk managers. Customers advised to locate and quarantine product, return to Biomet and identify any further customers receiving product. Recalled product is identified using specific lot and item numbers. Additionally, surgeons and hospital risk managers are to follow any specified patient monitoring instructions and return the Certificate of Acknowledgement to Zimmer Biomet. If you have further questions or concerns, please call customer service at 574-371-3071 or send questions via email to Corpor
Quantity2594
DistributionWorldwide: 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
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.