Z-1608-2016Class II

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

Name: Z-1608-2016 TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY
Creator: Applied Medical Technology Inc
Published: 2016-02-17
License: https://open.fda.gov/license/

Applied Medical Technology Inc / initiated 2016-02-17 / Terminated / root cause: packaging

FDA source

Applied Medical Technology Inc began a recall of TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a... on 2016-02-17. FDA classified it as Class II and gives the reason as "The firm received a complaint of an open pouch which breaches the sterilization validation". 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-1608-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-17
Posted: 2016-05-05
Terminated: 2016-10-27
Recalling firm: Applied Medical Technology Inc
Product: TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Product code: GAD Retractor
Reason for recall: The firm received a complaint of an open pouch which breaches the sterilization validation.
Root cause tag: packaging
FDA root cause: Packaging
Action: AMT sent an Urgent Medical Device Recall letter dated February 17, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 440-717-4000.
Quantity in commerce: 5,334 units
Distribution: Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.
Product codes and lots: Part #: M0068201750; Part #: M0068201761;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1608-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1608-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-04
Z-1609-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-04
Z-1610-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-04
Z-1611-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-04

Product code GAD

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)