Recall Z-1445-2019 ยท HTW Bit, Drill
Zimmer GmbH
V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 502015634
| Date | Apr 8, 2019 |
| Status | Terminated |
| Reason | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall notification letters dated 4/8/19 were sent to customers. |
| Distribution | The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152312 | RECON system-V-TEK-IVP Plates and Screws Normed Medizin-Technik GmbH, Oct 30, 2015 |