HammerTube 2.75mm Implant Recalled for Missing Titanium Plasma Coating
Paragon 28 recalls HammerTube implants missing their titanium plasma coating. Affected implants were distributed to facilities in Alabama, California, Georgia, Illinois, and Kentucky.
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: This is an FDA Class II recall of a medical implant with a manufacturing defect in which the titanium plasma coating is missing. This defect poses a theoretical risk to implant performance and biocompatibility. Per the recall rubric, a risk-of-harm product without reported illnesses or injuries qualifies as 'High' severity.
Plain-English summary
Paragon 28, Inc. is recalling HammerTube Implant, 2.75mm, 10° Cannulated units due to the absence of the titanium plasma coating on certain implants. This is a Class II recall.
The affected implants were distributed nationwide to healthcare facilities in Alabama, California, Georgia, Illinois, and Kentucky. The recalled lot is 26010822202, with Part Number P40-002-0275-S.
The missing titanium plasma coating may affect the implant's performance and biocompatibility.
The recalled product
- Product
- HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
- Manufacturer
- Paragon 28, Inc.
- Hazard
- Affected units
- 9
Distribution
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