TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue...
FDA Device Recall #Z-0685-2016 — Class II — November 25, 2015
Recall Summary
| Recall Number | Z-0685-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 25, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Abeon Medical Corporation |
| Location | Brecksville, OH |
| Product Type | Devices |
| Quantity | 1,035 units |
Product Description
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
Reason for Recall
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Distribution Pattern
Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CT,FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, NC, NH, NJ, OH, SC, TN, TX, UT, VA & WI., and the countries of Austria, Germany, Italy, Japan, Spain, Sweden & Switzerland.
Lot / Code Information
Part Number TLC200: Lot # 14121931 Exp Date 2017/12, Lot # 14121932 Exp Date 2017/12, Lot # 15010126 Exp Date 2018/01, Lot # 15013122 Exp Date 2018/01, Lot # 15013123 Exp Date 2018/01, Lot # 15024395 Exp Date 2018/02, Lot # 15024396 Exp Date 2018/02, Lot # 15031873 Exp Date 2018/03, Lot # 15032061 Exp Date 2017/12, Lot # 15034503 Exp Date 2017/10, Lot # 15040520 Exp Date 2018/02, Lot # 15041108 Exp Date 2017/12, Lot # 15044716 Exp Date 2018/04, Lot # 15050175 Exp Date 2018/01, Lot # 15051473 Exp Date 2018/05, Lot # 15051950 Exp Date 2018/04, Lot # 15054517 Exp Date 2018/05, Lot # 15062732 Exp Date 2018/04, Lot # 15070461 Exp Date 2018/02, Lot # 15070515 Exp Date 2018/02, Lot # 15076498 Exp Date 2018/07, Lot # 15080317 Exp Date 2018/01, Lot # 15090148 Exp Date 2018/07, Lot # 15090422 Exp Date 2018/03, Lot # 15092264 Exp Date 2018/01, Lot # 15095598 Exp Date 2018/09, Lot # 15102039 Exp Date 2018/05, Lot # 15103106 Exp Date 2018/09 & Lot # 15103112 Exp Date 2018/09. Part Number TLC300: Lot # 14122483 Exp Date 2017/12, Lot # 15010125 Exp Date 2018/01, Lot # 15010989 Exp Date 2017/12, Lot # 15023291 Exp Date 2017/10, Lot # 15034288 Exp Date 2018/03, Lot # 15034509 Exp Date 2017/12, Lot # 15033742 Exp Date 2018/03, Lot # 15042675 Exp Date 2018/03, Lot # 15053401 Exp Date 2017/12, Lot # 15054441 Exp Date 2018/01, Lot # 15062598 Exp Date 2018/06, Lot # 15062599 Exp Date 2018/06, Lot # 15064578 Exp Date 2018/01, Lot # 15070470 Exp Date 2018/03, Lot # 15070490 Exp Date 2018/03, Lot # 15081541 Exp Date 2018/03, Lot # 15082695 Exp Date 2018/03, Lot # 15090147 Exp Date 2018/06, Lot # 15095188 Exp Date 2018/06, Lot # 15110466 Exp Date 2018/06 & Lot # 15110476 Exp Date 2018/06.
Other Recalls from Abeon Medical Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0686-2016 | Class II | Wilson Penile Implantation System Retractor Fra... | Nov 25, 2015 |
| Z-0684-2016 | Class II | TLC¿ Self Retaining Retractor System Contents 1... | Nov 25, 2015 |
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.