ConMed Linvatec Recalls PopLok Bone Punch Due to Incorrect Shaft Diameter
ConMed Linvatec recalled one lot of PopLok bone punches because the metal shaft diameter was 4.5mm instead of the intended 3.5mm.
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 medical device with a significant dimensional defect (shaft diameter 1mm larger than intended) which poses a risk of harm during surgical use, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
ConMed Linvatec is recalling one lot of their PopLok bone punches, specifically the 3.5mm model. The recall was initiated because the metal shaft diameter of the affected units is 4.5mm, whereas it should have been 3.5mm.
The affected product is identified by Lot 318455. The recall involves two units that were distributed worldwide, including in the United States and Korea.
Healthcare providers and consumers should stop using the affected bone punches and contact the manufacturer for further instructions.
The recalled product
- Product
- PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Hazard
- Affected units
- 2
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 318455
Distribution
Distribution scope not specified by the agency.
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