CLASS II ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report

Universal Joints recalled by Medshape

Medshape is recalling Medshape Universal Joints, distributed nationwide in the US. The recall was initiated on 2 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921

Quantity recalled849

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-2513-2025
FDA event ID: 97064
Recalling firm: Medshape, Atlanta, GA
Classification: Class II
Status: Ongoing
Recall initiated: 2 Jun 2025
FDA classified: 3 Sep 2025
Reported: 10 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

2 Jun 2025	Recall initiated by company
3 Sep 2025	Classified by FDA	+93 days
10 Sep 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Medshape Universal Joints, REF: DNE-9000-UJ

Where it was distributed

US Nationwide distribution in the states of CA, IL, NJ, TX, FL, IN, OH, WI, VA, MA, SC, WA, NC, IA, MT, AZ, CO, NV, PA.

Nationwide Arizona California Colorado Florida Iowa Illinois Indiana Massachusetts Montana North Carolina New Jersey Nevada Ohio Pennsylvania South Carolina Texas Virginia Washington Wisconsin

Questions about this recall

Is Universal Joints recalled?

Yes. Medshape recalled Universal Joints on 2 Jun 2025. The recall is Class II and its status is Ongoing. Recall number Z-2513-2025.

Why was it recalled?

Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.

Which lots are affected?

UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921

Where was it sold?

US Nationwide distribution in the states of CA, IL, NJ, TX, FL, IN, OH, WI, VA, MA, SC, WA, NC, IA, MT, AZ, CO, NV, PA.

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 21 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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