Instrumed Recalls Zipser Meatus Clamps Due to Regulatory Non-Compliance
Instrumed International is withdrawing 81 Zipser Meatus Clamps because the company did not market the devices prior to 1976, failing to meet FDA requirements for pre-amendment devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is driven by regulatory documentation and marketing compliance issues rather than a physical defect or safety hazard. No injuries or illnesses are reported, fitting the criteria for a Low severity score.
Plain-English summary
Instrumed International, Inc. is voluntarily withdrawing 81 Zipser Meatus Clamps from the market. These instruments are used to compress and reduce blood flow to the penis to reduce pain. The devices are sold under various brand names, including Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro.
The reason for this withdrawal is that Instrumed did not market these devices prior to September 26, 1976. Consequently, the company does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. The affected units were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.
The source text does not specify specific actions for consumers or healthcare providers beyond the withdrawal of the devices from the market. No illnesses or injuries have been reported in connection with these devices.
The recalled product
- Product
- 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.
- Manufacturer
- Instrumed International, Inc.
- Affected units
- 81
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)
- 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"
- 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"
- 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"
- Trade Name: Medetz Surgical Instruments
- Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4"
- Medetz Surgical Instruments Item Number: 9-124570
Distribution
Part of a larger recall action
This product is one of 28 recalled by Instrumed International, Inc. 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.
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