Synthes Cannulated Distal Femoral Nail Recalled Due to Prior Recall Scope
Synthes USA is recalling one unit of a Cannulated Distal Femoral Nail because it was distributed despite being within the scope of a previous recall.
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: The recall involves a high-risk medical device (orthopedic implant) where a unit was distributed despite being subject to a previous recall. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or illnesses are mentioned in the source text.
Plain-English summary
Synthes USA HQ, Inc. is recalling one unit of the Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. The device is an orthopedic implant identified by Lot Number 7065061.
The recall was initiated because the firm discovered that this specific nail, which was within the scope of a previous Trauma Nail recall, had been distributed. The distribution pattern for this unit was limited to Massachusetts (MA).
Healthcare facilities and consumers who have this specific device should contact Synthes USA HQ, Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 1
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)
- Part Number 450.851S
- Lot Number 7065061
Distribution
Distributed in 1 state:
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