Recall Z-1303-2019 ยท HWC Screw, Fixation, Bone
Zimmer Biomet, Inc.
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 Hall
| Date | Mar 28, 2019 |
| Status | Terminated |
| Reason | There is a potential of fracture, bending or shearing of the driver. |
| Root cause | Under Investigation by 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. |
| Quantity | 1924 |
| Distribution | 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: |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142658 | Biomet Headless Compression and Twist-off Screws Biomet Manufacturing Corp, Nov 13, 2014 |