Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONL...

FDA Device Recall #Z-0684-2016 — Class II — November 25, 2015

Recall Summary

Recall Number Z-0684-2016
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 2,570 units

Product Description

TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.

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 M0068201750: Lot # 14112171 Exp Date 2017/11, Lot # 14112177 Exp Date 2017/11, Lot # 14120576 Exp Date 2017/05, Lot # 14120579 Exp Date 2017/11, Lot # 14121661 Exp Date 2017/12, Lot # 14121862 Exp Date 2017/12, Lot # 14121863 Exp Date 2017/12, Lot # 15010199 Exp Date 2017/12, Lot # 15010200 Exp Date 2017/12, Lot # 15011528 Exp Date 2018/01, Lot # 15011529 Exp Date 2018/01, Lot # 15011530 Exp Date 2018/01, Lot # 15011531 Exp Date 2018/01, Lot # 15012638 Exp Date 2017/12, Lot # 15012640 Exp Date 2017/11, Lot # 15013724 Exp Date 2017/11, Lot # 15013788 Exp Date 2018/01, Lot # 15013789 Exp Date 2018/01, Lot # 15013790 Exp Date 2018/01, Lot # 15013791 Exp Date 2018/01, Lot # 15020046 Exp Date 2018/01, Lot # 15020047 Exp Date 2017/12, Lot # 15020048 Exp Date 2018/01, Lot # 15021047 Exp Date 2018/01, Lot # 15021049 Exp Date 2018/01, Lot # 15021472 Exp Date 2018/02, Lot # 15021473 Exp Date 2018/02, Lot # 15021474 Exp Date 2018/02, Lot # 15024336 Exp Date 2018/01, Lot # 15030309 Exp Date 2018/01, Lot # 15030310 Exp Date 2017/11, Lot # 15030317 Exp Date 2018/01, Lot # 15032508 Exp Date 2018/03, Lot # 15034955 Exp Date 2018/03, Lot # 15035013 Exp Date 2018/03, Lot # 15040424 Exp Date 2018/02, Lot # 15040425 Exp Date 2018/01, Lot # 15040426 Exp Date 2018/01, Lot # 15040681 Exp Date 2018/04, Lot # 15040682 Exp Date 2018/04, Lot # 15041220 Exp Date 2018/04, Lot # 15050026 Exp Date 2018/01, Lot # 15050027 Exp Date 2018/03, Lot # 15050029 Exp Date 2018/03, Lot # 15061724 Exp Date 2018/04, Lot # 15061725 Exp Date 2018/04, Lot # 15082274 Exp Date 2018/04, Lot # 15082325 Exp Date 2018/04, Lot # 15082326 Exp Date 2018/05, Lot # 15082837 Exp Date 2018/08, Lot # 15082838 Exp Date 2018/08, Lot # 15082839 Exp Date 2018/08, Lot # 15084674 Exp Date 2018/08, Lot # 15084675 Exp Date 2018/08, Lot # 15084676 Exp Date 2018/08, Lot # 15084745 Exp Date 2018/08, Lot # 15084945 Exp Date 2018/08, Lot # 15084946 Exp Date 2018/08, Lot # 15090470 Exp Date 2018/08, Lot # 15090472 Exp Date 2018/08, Lot # 15090479 Exp Date 2018/08, Lot # 15090653 Exp Date 2018/09, Lot # 15092097 Exp Date 2018/09, Lot # 15092098 Exp Date 2018/09, Lot # 15092099 Exp Date 2018/09, Lot # 15092487 Exp Date 2018/08, Lot # 15092488 Exp Date 2018/08, Lot # 15092498 Exp Date 2018/09, Lot # 15092500 Exp Date 2018/09 & Lot # 15100350 Exp Date 2018/09. Part Number M0068201761: Lot # 14112771 Exp Date 2017/11, Lot # 14112177 Exp Date 2017/11, Lot # 14120578 Exp Date 2017/11, Lot # 14121661 Exp Date 2017/12, Lot # 14121861 Exp Date 2017/12, Lot # 15011528 Exp Date 2018/01, Lot # 15011530 Exp Date 2018/01, Lot # 15011531 Exp Date 2018/01, Lot # 15012621 Exp Date 2017/12, Lot # 15013728 Exp Date 2017/12, Lot # 15013788 Exp Date 2018/01, Lot # 15013791 Exp Date 2018/01, Lot # 15020050 Exp Date 2017/09, Lot # 15021047 Exp Date 2018/01, Lot # 15021048 Exp Date 2018/01, Lot # 15021050 Exp Date 2018/01, Lot # 15021472 Exp Date 2018/02, Lot # 15021473 Exp Date 2018/02, Lot # 15021474 Exp Date 2018/02, Lot # 15030318 Exp Date 2018/01, Lot # 15032367 Exp Date 2018/01, Lot # 15032370 Exp Date 2018/01, Lot # 15032507 Exp Date 2018/03, Lot # 15034955 Exp Date 2018/03, Lot # 15040428 Exp Date 2018/02, Lot # 15040681 Exp Date 2018/04, Lot # 15040682 Exp Date 2018/04, Lot # 15041281 Exp Date 2018/04, Lot # 15042333 Exp Date 2018/03, Lot # 15045081 Exp Date 2018/04, Lot # 15050030 Exp Date 2018/01, Lot # 15061726 Exp Date 2017/12, Lot # 15082837 Exp Date 2018/08, Lot # 15082839 Exp Date 2018/08, Lot # 15084674 Exp Date 2018/08, Lot # 15084675 Exp Date 2018/08, Lot # 15084946 Exp Date 2018/08, Lot # 15084947 Exp Date 2018/08, Lot # 15090461 Exp Date 2018/08, Lot # 15090480 Exp Date 2018/08, Lot # 15092097 Exp Date 2018/09 & Lot # 15092499 Exp Date 2018/08.

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-0685-2016 Class II TLC¿ Self-Retaining Retractor Frames SINGLE USE... 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.

More from Abeon Medical Corporation Recalls by Firm Recall Reasons Device Safety Stats