Recall Z-0453-2022 ยท HWC Screw, Fixation, Bone
Medshape, INC.
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
| Date | Nov 17, 2021 |
| Status | Open, Classified |
| Reason | The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure. |
| Root cause | Device Design |
| Action | The firm indicated that they will send recall notification to sales representatives via email or certified mail. Customers will be instructed to remove all +6 mm endcaps from stock and to return to the recalling firm with a return label that will be provided at a later date. Customers with questions are to contact the recalling firm at (678)235-3314. |
| Quantity | 26 units (1 count) |
| Distribution | Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203381 | Dynanail Mini Hybrid MedShape, Inc., Jan 15, 2021 |