Recall Z-0453-2022
Medshape, INC. · initiated November 17, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Codes / lots: Model No. 2600-05-006; Lot No. 04882; UDI: M97026000500060
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0453-2022
- Initiated
- November 17, 2021
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 26 units (1 count)
- Distribution
- Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.
- Recalling firm
- Medshape, INC., Atlanta, GA