Fibula nails recalled over out of specification thread depths on the implant
Paragon 28 is recalling 20 Phantom Fibula Nails because out of specification thread depths may prevent the implant from mating with its mounting bolt, potentially requiring surgery to be aborted.
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: Scored 3 under the risk-of-harm criterion: the firm states an affected implant may require surgery to be aborted, and no injuries are reported.
Plain-English summary
The Phantom Fibula Nail, 2.8mm x 130mm, right, titanium, REF P36-128-130R-S, from Paragon 28, is being recalled. The fibula nail system is intended for use in fixation of fibular fractures and osteotomies.
The nails have out of specification thread depths, so the implant may not be able to mate properly with the associated mounting bolt. The firm states that if the nail cannot properly mate with the instrumentation, the surgery potentially will need to be aborted.
The recall covers 20 units carrying UDI-DI 00889795133670, from lot 501182207125 with an expiration of March 13th, 2030. Distribution was nationwide in the United States, in New Jersey, Washington, New York, Maryland, California, Florida, New Mexico, Texas, Illinois, Ohio, Nevada, Tennessee and Louisiana. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Paragon 28's instructions.
The recalled product
- Product
- Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
- Manufacturer
- Paragon 28, Inc.
- Hazard
- out-of-specification
- implant
- instrument-mismatch
- aborted-procedure
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 (2)
- UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th
- 2030
Distribution
Distributed nationwide across the United States.
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