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U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0264-2027%22

Class II recall Z-0264-2027: restor3d Inc.

Q: How to monitor Class II recall Z-0264-2027: restor3d Inc. and peer other records

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Class II recall Z-0264-2027: restor3d Inc. (North Carolina): restor3d Inc. Dated 7 days ago, it is inside the fresh trigger window. Score 68/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 8 related NC FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0264-2027
Recalling firm	restor3d Inc.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description: The restor3d Metatarsophalangeal (MTP) Implant is a sterile, single-use implant grade metal device, available in varied articulating surface coverages. The restor3d MTP implant is designed to replace the damaged articulating surface of the first metatarsal distal head. The device is intended for the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the f
Reason	Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
Quantity	16
Distribution	U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.
Recall initiated	2026-09-04
Reported	2026-10-28
Firm location	Durham, NC, United States
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-28
Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: Class II recall Z-0264-2027: restor3d Inc. and 9 North Carolina peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

North Carolina FDAPulse records like this one: 9
Timing: High: dated in the last 7 days
Estimated pipeline if you contact every North Carolina peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

68 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 7 days ago.

What is the FDAPulse record for Class II recall Z-0264-2027: restor3d Inc. in North Carolina?

Class II device recall Z-0264-2027 by restor3d Inc.: Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilizat

How does Class II recall Z-0264-2027: restor3d Inc. compare to other North Carolina FDAPulse records?

It is fresh: dated 7 days ago, inside the window where early outreach matters most.

Class II recall Z-0264-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0264-2027	NC	2026-10-28
Class II recall Z-3155-2026	MA	2026-10-07
Class II recall Z-0232-2027		2026-10-28
Class II recall Z-0243-2027		2026-10-28

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