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Recall Observatory FDA recall evidence

Device product

T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.

Z-1303-2019

March 28, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 82640
Status
Terminated
Classification
Class II
Quantity
1924
Official record key
device-enforcement:Z-1303-2019

Official wording

Reason: There is a potential of fracture, bending or shearing of the driver.

Code information: Lot Numbers: 13421A 13811A 14042B 14048B 14140A 14194B 14343A 14392A 14393A 14394A 14518A 14601A 14827B 14895C 15015B 15167B 15257A 15392A

Distribution pattern: Worldwide Distribution - US Nationwide in the states: AK, AL, AR, AZ, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC< SD< TN, TX, UT, VA, VT, WA, WI, and WY. The products were distributed to the following foreign countries: Australia, Canada, Costa Rica, Malaysia, Netherlands, and Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential of fracture, bending or shearing of the driver.