External fixation universal joints recalled because pins may become dislodged
Medshape Universal Joints, REF DNE-9000-UJ, are recalled because a pin in the bone external fixation system can become dislodged, causing frame instability. 849 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; frame instability in an external fixation system that may require revision surgery is a potential harm, and no injuries are reported.
Plain-English summary
Medshape Universal Joints, REF DNE-9000-UJ, UDI-DI 00810028397101, are being recalled. Affected lots include 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921 and 32422, with the full list in the recall notice. The recall covers 849 units distributed across more than 15 states.
The bone external fixation system may have a pin that can become dislodged, resulting in frame instability. The manufacturer states that use of the product may cause a delay in surgery, or a revision if the device is used. The FDA classified the action as Class II.
Hospitals and surgical centres holding these lots should quarantine them and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Medshape Universal Joints, REF: DNE-9000-UJ
- Manufacturer
- Medshape, INC.
- Affected units
- 849
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 (14)
- UDI-DI: 00810028397101 Lots : 001927
- 002274
- 002301
- 002309
- 002314
- 002322
- 002535
- 009389
- 090921
- 32422
- 5432
- 5875
- 61120
- 90921
Distribution
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