DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Reported: January 12, 2022 Initiated: November 17, 2021 #Z-0453-2022
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.
Details
- Recalling Firm
- Medshape, INC.
- Units Affected
- 26 units (1 count)
- Distribution
- Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile. Recalled by Medshape, INC.. Units affected: 26 units (1 count).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 12, 2022. Severity: Moderate. Recall number: Z-0453-2022.
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