CLASS II Device recall · Reported 11 May 2016 · FDA Enforcement Report
Wilson Penile Implantation System Retractor Frame recalled
Applied Medical Technology is recalling Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation, distributed in 28 states. The recall was initiated on 17 Feb 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1610-2016
- FDA event ID
- 73318
- Recalling firm
- Applied Medical Technology, Brecksville, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Feb 2016
- FDA classified
- 4 May 2016
- Reported
- 11 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 17 Feb 2016 | Recall initiated by company | |
| 4 May 2016 | Classified by FDA | +77 days |
| 11 May 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm received a complaint of an open pouch which breaches the sterilization validation.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
AlabamaArkansasArizonaCaliforniaConnecticutFloridaGeorgiaIowaIndianaKansasKentuckyMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNebraskaNew HampshireNew Jersey
Questions about this recall
Why was it recalled?
The firm received a complaint of an open pouch which breaches the sterilization validation.
Which lots are affected?
Part #: TLC5042 & TLC5042-I
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 73318| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tlc¿ Self-Retaining Retractor Frames Single Use Only recalled | Applied Medical Technology | Sterility | 28 states | |
| CLASS II | Wilson Implantation System recalled by Applied Medical Technology | Applied Medical Technology | Sterility | 28 states | |
| CLASS II | Tlc¿ Self Retaining Retractor System Contents 1-Retractor recalled | Applied Medical Technology | Sterility | 28 states |
More recalls from Applied Medical Technology
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit recalled | Applied Medical Technology | Other | Nationwide |
| Device | CLASS II | NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit recalled | Applied Medical Technology | Other | Nationwide |
| Device | CLASS II | NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit recalled | Applied Medical Technology | Other | Nationwide |
| Device | CLASS II | NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit recalled | Applied Medical Technology | Other | Nationwide |
| Device | CLASS II | NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit recalled | Applied Medical Technology | Other | Nationwide |
Other Surgical Instruments recalls
All 3,902| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline surgical convenience kits labeled as: EAR recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Scout MD recalled by Merit Medical Systems | Merit Medical Systems | Other | 7 states |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |