CLASS II ONGOING Device recall · Reported 12 Jan 2022 · FDA Enforcement Report
Dynanail Mini, Endcap + recalled by Medshape
Medshape is recalling Dynanail Mini, Endcap +, distributed in 9 states. The recall was initiated on 17 Nov 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0453-2022
- FDA event ID
- 89117
- Recalling firm
- Medshape, Atlanta, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Nov 2021
- FDA classified
- 4 Jan 2022
- Reported
- 12 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Nov 2021 | Recall initiated by company | |
| 4 Jan 2022 | Classified by FDA | +48 days |
| 12 Jan 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Where it was distributed
Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.
CaliforniaFloridaGeorgiaIllinoisIndianaMassachusettsMarylandTexasWashington
Questions about this recall
Why was it 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 lots are affected?
Model No. 2600-05-006; Lot No. 04882; UDI: M97026000500060
Where was it sold?
Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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