Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73318

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 17, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Applied Medical Technology Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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.

Z-1608-2016
Recall number
Z-1608-2016
Initiated
February 17, 2016
Classification
Class II
Status
Terminated
Quantity
5,334 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open pouch

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received a complaint of an open pouch which breaches the sterilization validation.

Code information

Part #: M0068201750; Part #: M0068201761;

Distribution pattern

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.

device · product 2 of 4

TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

Z-1609-2016
Recall number
Z-1609-2016
Initiated
February 17, 2016
Classification
Class II
Status
Terminated
Quantity
3,754 Units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open pouch

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received a complaint of an open pouch which breaches the sterilization validation.

Code information

Part #: TLC200 & TLC300

Distribution pattern

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.

device · product 3 of 4

Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

Z-1610-2016
Recall number
Z-1610-2016
Initiated
February 17, 2016
Classification
Class II
Status
Terminated
Quantity
2,263 Units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open pouch

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received a complaint of an open pouch which breaches the sterilization validation.

Code information

Part #: TLC5042 & TLC5042-I

Distribution pattern

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.

device · product 4 of 4

Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

Z-1611-2016
Recall number
Z-1611-2016
Initiated
February 17, 2016
Classification
Class II
Status
Terminated
Quantity
1,100 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open pouch

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received a complaint of an open pouch which breaches the sterilization validation.

Code information

Part #: TLC5042-M

Distribution pattern

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.