DRILL BIT recallZ-0812-2022 · Biomet, Inc. · initiated Feb 14, 2022

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

A 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 [email protected]

Recall details

Recall number

Z-0812-2022

Status

Terminated

Initiated by the company

Feb 14, 2022

Recalling firm

Biomet, Inc.

Quantity

2594

Product code

JDR

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

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.

Devices named in this recall

8 devices in the FDA device registry whose identifier appears in the recall's code information.

• A.L.P.S.® 2142-27-160

  Biomet Orthopedics, LLC · BIT, DRILL
  1 recall9 reports
• DRILL BIT 212000022

  Biomet Orthopedics, LLC · BIT, DRILL
  1 recall3 reports
• A.L.P.S.® 8290-29-170

  Biomet Orthopedics, LLC · BIT, DRILL
  1 recall3 reports
• A.L.P.S.® 8241-50-170

  Biomet Orthopedics, LLC · TAP, BONE
  1 recall0 reports
• A.L.P.S.® 8290-32-170

  Biomet Orthopedics, LLC · BIT, DRILL
  1 recall0 reports
• A.L.P.S.® 8295-16-150

  Biomet Orthopedics, LLC · Guide, surgical, instrument
  1 recall0 reports
• A.L.P.S.® 8295-16-151

  Biomet Orthopedics, LLC · Guide, surgical, instrument
  1 recall0 reports
• A.L.P.S.® 8242-73-100

  Biomet Orthopedics, LLC · BIT, DRILL
  1 recall0 reports

Product lines

• DRILL BITBiomet Orthopedics, LLC · 3 models · 5 reports · 1 recall

Other products in the same recall event

The FDA groups related products into one recall event (event 89701).

• Z-0809-2022 · Terminated
  BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum …
• Z-0810-2022 · Terminated
  BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA…
• Z-0811-2022 · Terminated
  BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriat…