Z-1302-2019 Class II Terminated
FDA device recall Z-1302-2019 was initiated by Zimmer Biomet, Inc. on March 28, 2019 and is designated Class II. Reason for recall: There is a potential of fracture, bending or shearing of the driver. The recall status is terminated (terminated June 2, 2020). Affected quantity: 5885.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2019
- Initiation Date
- March 28, 2019
- Termination Date
- June 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5885
Product Description
T7 Driver Cannulated AO (Part Number 110018531) 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 for Recall
There is a potential of fracture, bending or shearing of the driver.
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.
Code Information
Lot Numbers: 13422A 13869A 13870A 14042A 14048A 14090A 14090B 14090C 14090D 14090E 14194A 14194C 14194E 14194F 14194G 14224A 14827A 14827C 14827D 14827E 14827F 14895A 14895B 15015A 15167A 15167C 15310A 15310B