ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The An...
FDA Device Recall #Z-1304-2019 — Class II — March 21, 2019
Recall Summary
| Recall Number | Z-1304-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 21, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Conmed Corporation |
| Location | Utica, NY |
| Product Type | Devices |
| Quantity | 69385 |
Product Description
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 laparoscopic surgery.
Reason for Recall
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
Distribution Pattern
Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden.
Lot / Code Information
Lot codes for product manufactured to and including the dates listed below, with the exclusions noted below for each catalog number: Beginning Manufacture Date: April 26, 2018 Beginning Lot Code: 20180426X Ending Manufacture Date: February 15, 2019 Ending Lot Code: 20190215X Excluded Anchor Tissue Retrieval System" Lot Codes - 1. All alpha/numeric lot codes (e.g. lots 68A8T or 19A8T) 2. All numeric lot codes ending with the number 9 (e.g. Lot code 201902159) 3. All excluded numeric lot codes listed in the tables below for each specific catalog number: Excluded Lot Codes for Cat. Number TRS100SB2: 201805095 201806055 201809265 201810314 201811224 201812114 201805144 201806115 201809285 201811054 201811234 201812124 201805145 201807134 201810014 201811064 201811264 201812144 201805194 201807245 201810094 201811074 201811274 201812174 201805214 201808155 201810154 201811084 201811284 201812184 201805255 201808164 201810164 201811124 201811304 201812204 201805284 201808165 201810184 201811134 201812034 201812214 201805295 201808205 201810194 201811144 201812044 201901024 201805315 201808214 201810224 201811154 201812054 201901034 201806015 201808225 201810234 201811164 201812064 201901044 201806045 201808234 201810244 201811204 201812074 201901074 201806054 201809255 201810254 201811214 201812104 -----
Other Recalls from Conmed Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0474-2023 | Class II | Foot Controlled Electrosurgical Suction Coagula... | Nov 18, 2022 |
| Z-1499-2021 | Class II | KIT_INFINITY_BASE Custom Procedural Kit - Italy... | Mar 26, 2021 |
| Z-1498-2021 | Class II | INFINITY_TRAY Custom Procedural Kit - Canada. ... | Mar 26, 2021 |
| Z-0651-2021 | Class II | Infinity ACL Tibial Tip Guide- indicated for u... | Nov 12, 2020 |
| Z-0650-2021 | Class II | Infinity ACL Tibial Elbow Guide-indicated for u... | Nov 12, 2020 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.