Wilson Penile Implantation System Retractor Frame — Class II medical device recall Z-1610-2016
Terminated recall by Applied Medical Technology Inc, reported 2016-05-11, distributed in AL, AR, AZ, CA, CT, FL, GA, IA…. The firm received a complaint of an open pouch which breaches the sterilization validation.
| Recall number | Z-1610-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Applied Medical Technology Inc, Brecksville, OH, United States |
| Recall initiated | 2016-02-17 |
| Classified | 2016-05-04 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2016-10-27 |
| Distributed | 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 |
| Countries outside the US | AT, CH, DE, DK, ES, GB, IT, JP, NO, SE |
| Quantity | 2,263 units |
| Model numbers | TLC5042, TLC5042-I |
Product
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.
Reason for recall
The firm received a complaint of an open pouch which breaches the sterilization validation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1610-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.