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Terminated

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.

FDA Recall Z-1303-2019 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2019-03-28
Date Terminated2020-06-02
Product Quantity1924

Reason for Recall

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

Firm Action

Urgent Medical Device Removal and Notice of Discontinuation notification letters dated 3/28/19 were sent to customers. The letter identified the affected product problem and actions to be taken. For questions or concerns call customer service at 574-371-307.

Root Cause

Under Investigation by firm

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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