Food, drugs, devices › Ace Surgical Supply Co., Inc.
Device recall: Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
FDA enforcement event 79798 is a device recall by Ace Surgical Supply Co., Inc. of Brockton, MA, initiated 28 Mar 2018 and classified Class II, with 1 product record.
FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 11 Sep 2018. Initiation: voluntary: firm initiated. Ace Surgical Supply Co., Inc. has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ace Surgical Supply Co., Inc., Brockton, MA.
Reason for recall
"The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade."
Distribution
"US Distribution to the states of : MI, CA, OK, and Internationally to China, Canada,"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1464-2018 | Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity. | 6 | Class II | Terminated | 2 May 2018 |
Context
Other enforcement events for Ace Surgical Supply Co., Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Feb 2022 | NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 509925 | Device | Class II | 1 |
| 24 Oct 2017 | Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA | Drug | Class II | 1 |
| 22 Feb 2017 | INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: | Device | Class II | 1 |
All 4 events for Ace Surgical Supply Co., Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to the states of : MI, CA, OK, and Internationally to China, Canada,"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Sep 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.