ConMed Anchor Tissue Retrieval System Recalled for Seal Defects
ConMed is recalling Anchor Tissue Retrieval Systems because voids or partial seals may compromise sterility. The recall covers units distributed worldwide.
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 sterile medical device where a seal defect may compromise sterility, posing a risk of infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ConMed Corporation is recalling the Anchor Tissue Retrieval System, a sterile disposable pouch used during laparoscopic surgery to remove organs or tissue. The recall is due to defects in the product's seal, specifically voids or partial seals that create an open channel. These defects may compromise the sterility of the product.
The recall affects 69,385 units of the Anchor Tissue Retrieval System, Catalog Number TRS100SB2. The affected units were manufactured between April 26, 2018, and February 15, 2019. Specific lot codes are excluded from this recall, including all alpha/numeric lot codes and numeric lot codes ending in the number 9. The source text lists specific excluded numeric lot codes for the affected catalog number.
The product was distributed nationwide in the United States and in several international countries, including Austria, Canada, Denmark, Great Britain, Ireland, Japan, the Netherlands, Oman, Poland, Qatar, Romania, Singapore, Spain, and Sweden. Users should check their inventory for the affected catalog number and lot codes. If the product is found, it should be removed from use and returned to ConMed Corporation according to their instructions.
The recalled product
- Product
- ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during…
- Manufacturer
- Conmed Corporation
- Affected units
- 69,385
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 (2)
- Lot codes for product manufactured to and including the dates listed below
- 2018 Beginning Lot Code: 20180426X Ending Manufacture Date: February 15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Conmed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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