ConMed Recalls Nonabsorbable Suture Anchor System Due to Manufacturing Error
ConMed Corporation is recalling 56 units of a nonabsorbable suture anchor system because they were manufactured with the incorrect anchor outer body.
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 2/5 (Moderate).
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, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report any injuries, illnesses, or deaths, and the defect is a manufacturing error regarding the anchor body.
Plain-English summary
ConMed Corporation is recalling 56 units of a nonabsorbable suture anchor system. The product is intended to reattach soft tissue to bone in orthopedic surgical procedures and may be used in either arthroscopic or open surgical procedures.
The recall was initiated because the devices were manufactured with the incorrect anchor outer body. The affected units are identified by Lot Number 786351.
The recalled products were distributed to facilities in California, Indiana, Kansas, Maryland, New York, Ohio, Pennsylvania, Tennessee, Texas, and Wisconsin. Healthcare providers should stop using the affected devices and contact ConMed Corporation for further instructions.
The recalled product
- Product
- Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.
- Manufacturer
- ConMed Corporation
- Hazard
- Affected units
- 56
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 Number 786351
Distribution
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