Z-0685-2016Class II

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

Name: Z-0685-2016 TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction...
Creator: Abeon Medical Corporation
Published: 2015-11-25
License: https://open.fda.gov/license/

Abeon Medical Corporation / initiated 2015-11-25 / Terminated / root cause: packaging

FDA source

Abeon Medical Corporation began a recall of TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure on 2015-11-25. FDA classified it as Class II and gives the reason as "The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0685-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Posted: 2016-01-21
Terminated: 2016-10-27
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.
Product code: FFO Retractor, Self-Retaining
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.
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0685-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0684-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21
Z-0685-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21
Z-0686-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21

Product code FFO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)