Recall events
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Event 89983
Event summary
Timeline bucket March 30, 2022
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording restor3d Inc.
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
3 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
Z-1026-2022
Recall number Z-1026-2022
Initiated March 30, 2022
Classification Class II
Status Terminated
Quantity 14 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1026-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[26850]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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Inspect official wording and provenance
Reason for recall Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Code information Model: 6110-N01-KTS01 Lot: 2022030005 UDI: 00840097504506
Distribution pattern US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32723]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Z-1027-2022
Recall number Z-1027-2022
Initiated March 30, 2022
Classification Class II
Status Terminated
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1027-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45341]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Compare all device evidence states
Inspect official wording and provenance
Reason for recall During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Code information Model: 6101-20181018; Lot: 2022010031; UDI: 00840097501574
Distribution pattern US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34945]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
Z-1028-2022
Recall number Z-1028-2022
Initiated March 30, 2022
Classification Class II
Status Terminated
Quantity 9 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1028-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51779]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Code information Model: 6101-22200818; Lot: 2022010035; UDI: 00840097501598
Distribution pattern US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32729]
FDA event record
· Exact recall-number query on openFDA
