Medshape DYNANAIL MINI surgical nail recalled for improper endcap length
Medshape is recalling DYNANAIL MINI surgical nails due to manufacturing defect in lot 04882. Affected endcaps may not seat flush during surgical insertion, potentially affecting implant integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall affecting a surgical implant with manufacturing defect creating risk of improper fit during procedures. No injuries have been reported. Per the rubric, this qualifies as High (3) as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medshape, INC. is recalling specific units of the DYNANAIL MINI, Endcap +6mm (Model 2600-05-006), a sterile surgical implant used in orthopedic procedures. The recall affects only units from Lot 04882.
The recalled units were manufactured with endcaps longer than specified in product specifications. This manufacturing defect creates a risk that the endcap will not seat flush against the nail during surgical insertion, potentially affecting the integrity and function of the implant during the procedure.
The recalled units were distributed domestically to California, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Texas, and Washington.
Patients and physicians who have received this product from the affected lot should contact Medshape, INC. for instructions on how to proceed. Healthcare providers should verify lot numbers before surgical use and quarantine any units from Lot 04882.
The recalled product
- Product
- DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
- Manufacturer
- Medshape, INC.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. 2600-05-006
- Lot No. 04882
- UDI: M97026000500060
Distribution
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