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

Recall number

Z-0685-2016

Recalling firm

Abeon Medical Corporation

Product

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

Status

Terminated

Initiated

2015-11-25

Posted

not on file

Terminated

2016-10-27

Reason

The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.

Root cause

Packaging

Action

On 12/17/2015 the firm sent Recall Notification Letters to their customers. The letter identified the product, problem, and actions to be taken by the customer.

Quantity

1,035 units

Distribution

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, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

FFO

Firm FEI

3008657512

Firm city

Brecksville

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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