Z-1464-2018Class II

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

Name: Z-1464-2018 Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral...
Creator: Ace Surgical Supply Co., Inc.
Published: 2018-03-28
License: https://open.fda.gov/license/

Ace Surgical Supply Co., Inc. / initiated 2018-03-28 / Terminated / root cause: labeling and UDI

FDA source

Ace Surgical Supply Co., Inc. began a recall of Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity on 2018-03-28. FDA classified it as Class II and gives the reason as "The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1464-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-28
Posted: 2018-04-20
Terminated: 2018-09-11
Recalling firm: Ace Surgical Supply Co., Inc.
Product: Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
Product code: EMO Knife, Periodontic
Reason for recall: The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: ACE is contacting the 5 affected customers via certified mail for US customers and via email for non-US Customers. Follow-up notifications will be sent 12 weeks after initial notification. Firm will rework incorrectly packaged product and will use completed reply forms as effectiveness check. For further questions, please call (508) 588-3100.
Quantity in commerce: 6
Distribution: US Distribution to the states of : MI, CA, OK, and Internationally to China, Canada,
Product codes and lots: Lot # M050225

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1464-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1464-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20

Product code EMO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)