RecallRadar

FDA Device recall Z-1303-2019

T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fix…

On 2019-05-15 the FDA classified a Class II recall of T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fix… by Zimmer Biomet, citing there is a potential of fracture, bending or shearing of the driver.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1303-2019
ClassificationClass II
Statusterminated
Initiated2019-03-28
Published2019-05-15
Last updated2026-09-13 11:55 UTC
CompanyZimmer Biomet
DistributionUS

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.

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1303-2019%22

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