Integra Advansys Medial Lisfranc Plate Recalled for Surgical Technique Risk
Integra LifeSciences is recalling Advansys Medial Lisfranc Plates because an incorrect surgical technique may cause potential rupture of the tibialis anterior tendon.
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 (tendon rupture) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Integra LifeSciences Corp. is recalling the Advansys Medial Lisfranc Plate (MLP) due to a potential safety risk associated with the surgical technique used during implantation. The recall involves 2,437 units of the device, which is intended for bone fixation procedures such as arthrodesis of the 1st metatarsocuneiform joint, Lisfranc arthrodesis, and osteotomies or fractures near the 1st metatarsocuneiform joint.
The recall was initiated because an incorrect technique applied during surgery may cause potential rupture of the tibialis anterior tendon. The affected devices were distributed worldwide, including to various U.S. states and international locations such as Belgium, France, Germany, and the United Kingdom. Specific model and batch numbers are listed in the agency's recall record.
Healthcare providers and patients who have received this device should contact their surgeon or the recalling firm for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc…
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 2,437
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)
- Model #181041S
- Batch #s EKU8
- EN2D
- EN2B
- EMOK & EN2B
- Model #181051S
- Batch #s EJQY
- FOSU
- ECEB & E179
- Model #181041
- Batch #s EB1E
- EBKY
- ECE9
- EHA7
- E647
- E8NP
- E8P7
- E8ML
- E8N5
- E8PV
Distribution
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