Abeon Wilson Penile Implantation System Retractor Frame Recalled for Sterility Compromise
Abeon Medical Corporation is recalling Wilson Penile Implantation System Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a compromised sterile barrier for a surgical device, which poses a risk of infection, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Abeon Medical Corporation is recalling 575 units of the Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap. The product is a single-use, prescription-only medical device indicated to aid in tissue retraction during a surgical procedure.
The recall was initiated after the firm was notified by some customers that certain sealed pouches contain tears. These tears compromise the sterility of the product, which is a critical requirement for single-use surgical instruments.
The affected units were distributed worldwide, including nationwide in the United States and in Austria, Germany, Italy, Japan, Spain, Sweden, and Switzerland. The recall covers specific lot numbers for Part Numbers TLC5042 and TLC5042-I, with expiration dates ranging from June 2017 to October 2018. Healthcare providers and facilities should stop using the affected lots and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
- Manufacturer
- Abeon Medical Corporation
- Affected units
- 575
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part Number TLC5042: Lot # 14121931 Exp Date 2017/12
- Lot # 15010126 Exp Date 2018/01
- Lot # 15013122 Exp Date 2018/01
- Lot # 15013123 Exp Date 2018/01
- Lot # 15021046 Exp Date 2018/01
- Lot # 15021051 Exp Date 2018/01
- Lot # 15024395 Exp Date 2018/02
- Lot # 15031873 Exp Date 2018/03
- Lot # 15033220 Exp Date 2018/02
- Lot # 15040515 Exp Date 2017/06
- Lot # 15044161 Exp Date 2017/12
- Lot # 15044717 Exp Date 2018/04
- Lot # 15050167 Exp Date 2017/12
- Lot # 15051473 Exp Date 2018/05
- Lot # 15051474 Exp Date 2018/05
- Lot # 15062728 Exp Date 2017/12
- Lot # 15070483 Exp Date 2018/01
- Lot # 15070485 Exp Date 2018/01
- Lot # 15074959 Exp Date 2018/07
- Lot # 15075862 Exp Date 2018/01
Distribution
Part of a larger recall action
This product is one of 3 recalled by Abeon Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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See all →- HighAbeon Medical Recalls TLC Self Retaining Retractor System Due to Sterility Compromise
FDA (Devices) · 2016-01-27
- HighAbeon Medical Recalls Self-Retaining Retractor Frames Due to Sterility Compromise
FDA (Devices) · 2016-01-27
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