The Recall Desk
LowFDA (Devices)·Z-1464-2018·Announced 2018-05-02

Ace Surgical Supply Recalls Mispackaged Double Blade Shoe Unigraft Knives

Ace Surgical Supply Co., Inc. is recalling six units of Double Blade Shoe F/Unigraft Knives because a single blade shoe was mistakenly packaged instead of the intended double blade.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is a packaging-only problem involving a mispackaged component with no reported injuries or illnesses, fitting the criteria for a Low severity recall.

Plain-English summary

Ace Surgical Supply Co., Inc. is recalling six units of Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM (SKU 6500009, Lot # M050225). These medical devices are used to achieve epithelial grafts in the oral cavity.

The recall was initiated because the product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of the intended double blade.

The affected units were distributed in the United States to Michigan, California, and Oklahoma, as well as internationally to China and Canada. Consumers and healthcare providers should stop using the product and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
Affected units
6

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 (1)

  • Lot # M050225

Distribution

Distributed in 3 states:

Same manufacturer · Ace Surgical Supply Co., Inc.

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