Integra Recalls Panta Nails Due to Potential Sterility Seal Issues
Integra LifeSciences is voluntarily recalling Panta and Panta XI Nails because package seals may not maintain intended sterility.
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 involves a risk-of-harm product (sterile medical device) where the hazard is a potential loss of sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Integra LifeSciences Corp. is voluntarily recalling Panta and Panta XI Nails. The recall is due to a potential issue where the internal and external package seal may not provide the level of sterility intended for the device.
The recall involves 4,449 units of Panta Nails (Reference/Model #500050ND through #500380ND) and Panta XL Nails (Reference/Model #510111ND through #510341ND). Specific lot numbers are listed in the structured product information. The affected products were distributed US Nationwide and Internationally.
Healthcare providers and patients should stop using the recalled Panta and Panta XI Nails. Users should contact their healthcare provider or the manufacturer for further instructions on how to proceed.
The recalled product
- Product
- Panta Nail, Rx only, Sterile,
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 4,449
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 (20)
- Panta Nails - Reference/Model #500050ND - Lot #'s: F33A
- F33B
- F3BN
- F3Y5
- F3Y6
- F4S4
- F56Y
- F5LZ
- F64W
- F7C8
- F7C9
- F8SZ
- F9PC
- FCUG
- FCUH
- FEDW
- FEVR
- FGAX
- FGLN and FHLP
- Reference/Model #500080ND - Lot #'s: F0F1
Distribution
Distributed nationwide across the United States.
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