Paragon 28 Recalls Mislabelled Titan 3-D Wedge Implants
Paragon 28, Inc. is recalling 64 Titan 3-D Wedge implant kits because they are permanently mislabeled with the wrong size, which could cause surgical delays.
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: The recall is classified as FDA Class II and involves a risk of harm (improper surgical site preparation and delays) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Paragon 28, Inc. is recalling 64 units of the P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile implant kit (REF P03-EVN-1010-S, Lot # BR4108). The recall is due to a permanent labeling error where the 10 mm wedge implant is incorrectly marked as a 12 mm size.
The use of these mislabeled products could result in improper preparation of the surgical site, potentially causing delays in surgery. The affected units were distributed to healthcare facilities in 33 U.S. states and the District of Columbia, as well as in Australia and Israel.
Healthcare providers and consumers should stop using the affected implant kits immediately. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
- Manufacturer
- Paragon 28, Inc.
- Affected units
- 64
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 (1)
- Lot # BR4108
Distribution
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