Z-0453-2022Class II

DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile

Name: Z-0453-2022 DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Creator: Medshape, INC.
Published: 2021-11-17
License: https://open.fda.gov/license/

Medshape, Inc. / initiated 2021-11-17 / Open, Classified / root cause: design

FDA source

Medshape, INC. began a recall of DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile on 2021-11-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0453-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-17
Posted: 2022-01-04
Recalling firm: Medshape, Inc.
Product: DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Product code: HWC Screw, Fixation, Bone
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 26 units (1 count)
Distribution: Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.
Product codes and lots: Model No. 2600-05-006; Lot No. 04882; UDI: M97026000500060

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0453-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0453-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-12	2022-01-04

Product code HWC

K203381Class IIDynanail Mini HybridMedShape, Inc. / cleared 2021-01-15

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)