Recall Z-0453-2022— Medshape, INC.
Class II · Ongoing
Class II FDA medical device recall by Medshape, INC., initiated 2021-11-17. It names one FDA 510(k) clearance: K203381. Product: DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile. 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..
- Recalling firm
- Medshape, INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-11-17
- Firm location
- Atlanta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.