Abeon Medical Corporation: Medical Device Recall in 2016 - (Recall #: Z-0685-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.

Product Classification:

Class II

Date Initiated: November 25, 2015

Date Posted: January 27, 2016

Recall Number: Z-0685-2016

Event ID: 72836

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.

Status: Terminated

Product Quantity: 1,035 units

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated