Medshape Universal Joints Recalled for Pin Dislodgement and Frame Instability
Medshape Universal Joints (REF: DNE-9000-UJ) used in bone external fixation are recalled because securing pins can become dislodged, causing frame instability that may delay surgery or require device revision.
What this means for you
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: This FDA Class II medical device recall involves a risk-of-harm product (bone external fixation system) where no illnesses or injuries have been reported. The hazard—pin dislodgement causing frame instability—meets the High severity criterion for structural device defects without reported injury.
Plain-English summary
Medshape Universal Joints (model DNE-9000-UJ) used in bone external fixation systems are being recalled. The pins that secure the fixation frame may become dislodged, causing loss of frame stability.
When a pin becomes dislodged, the external fixation frame loses structural integrity. This can delay surgery or require revision of the device.
Approximately 849 units have been distributed nationwide across 18 states including California, Illinois, New Jersey, Texas, Florida, Indiana, Ohio, Wisconsin, Virginia, Massachusetts, South Carolina, Washington, North Carolina, Iowa, Montana, Arizona, Colorado, Nevada, and Pennsylvania. Affected lot numbers are: 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, and 90921 (UDI-DI: 00810028397101).
The recalled product
- Product
- Medshape Universal Joints, REF: DNE-9000-UJ
- Manufacturer
- Medshape, INC.
- Hazard
- pin-dislodgement
- frame-instability
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
Distributed nationwide across the United States.
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