ConMed Linvatec Recalls Mis-assembled CrossFT Punches for Suture Anchor Insertion
ConMed Linvatec is recalling 2 units of CrossFT Punches (Lot 330889) because they were mis-assembled with the incorrect handle.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a manufacturing assembly error (incorrect handle) rather than a high-risk pathogen or structural defect causing reported injuries, fitting the criteria for a moderate severity recall.
Plain-English summary
ConMed Linvatec is recalling 2 units of the CrossFT Punch (Catalog PFT-00M, Lot 330889). This medical device is used to create a pathway for the insertion of CrossFT Suture Anchors into bone.
The recall was initiated because the punch was mis-assembled with the incorrect handle. The correct handle for this device is a clear anodized silver colored handle.
The affected units were distributed worldwide, including nationwide in the United States (specifically noting the state of Minnesota) and in Thailand. Users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
- 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 # 330889 and Catalog: PFT-00M - No Expiration date
Distribution
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