Instrumed International, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0534-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.

Product Classification:

Class II

Date Initiated: September 8, 2014

Date Posted: December 17, 2014

Recall Number: Z-0534-2015

Event ID: 69471

Reason for Recall:

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.

Status: Terminated

Product Quantity: 81 clamps

Code Information:

1) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medline Industries; Medline Industries Product Name: CLAMP, ZIPSER MEATUS, OVERALL LGTH 4-1/4; Medline Industries Item Number: MDG5597111; Lot Numbers: 051208, 060810. 2) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Boss Instruments; Boss Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Boss Instruments Item Number: 46-5195; Lot Number: 060810. 3) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4"; Millennium Surgical Item Number: 9-124570; Lot Number: 060810. 4) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810. 5) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810. 6) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4"; Millennium Surgical Item Number: 9-124570; Lot Numbers: 060810, 080713, 082213. 7) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Surgical Direct; Surgical Direct Product Name: Zipser Meatus Clamp 4 1/4"; Surgical Direct Item Number: SD16450.100; Lot Number: 060810. 8) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Surgipro; Surgipro Product Name: Zipser Meatus Clamp 4 1/4"; Surgipro Item Number: SPGU-4570; Lot Number: 060810.

Distribution Pattern:

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated