DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
This recall is currently active, issued November 17, 2021. It was issued by Medshape, Inc..
- Company
- Medshape, Inc.
- Recall Initiated
- November 17, 2021
- Recall Number
- Z-0453-2022
- Quantity
- 26 units (1 count)
- Firm Location
- Atlanta, GA
- Official Source
- View on FDA website ↗
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.
Distribution
Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.
Lot / Code Info
Model No. 2600-05-006; Lot No. 04882; UDI: M97026000500060
Root 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.