Summary
The FDA issued a Class II for DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile by Medshape, INC.. Reason: The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications,.
Details
Source
Device Recall
External ID
Z-0453-2022
Action Date
2022-01-12
Status
Ongoing
Category
device
Product Description
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Lot/Code Info: Model No. 2600-05-006; Lot No. 04882; UDI: M97026000500060
Quantity Affected: 26 units (1 count)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-17
Company
Atlanta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medshape, INC. has 7 FDA actions in our database, including 2 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medshape, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medshape, INC. have FDA actions?
Medshape, INC. has 7 FDA actions in our database, including 2 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0453-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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