Z-1028-2022Class II

Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual...

Name: Z-1028-2022 Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual...
Creator: restor3d Inc.
Published: 2022-03-30
License: https://open.fda.gov/license/

restor3d, Inc. / initiated 2022-03-30 / Terminated

FDA source

restor3d Inc. began a recall of Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument on 2022-03-30. FDA classified it as Class II and gives the reason as "During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1028-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-30
Posted: 2022-04-29
Terminated: 2023-08-28
Recalling firm: restor3d, Inc.
Product: Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
Product code: LXH Orthopedic Manual Surgical Instrument
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.
FDA root cause: Process change control
Action: An email was sent out to the consignees on 03/31/2022. All customers were instructed to segregate any affected product and contact Restor3d. If all product has already been returned to restor3d, the consignee is to indicate that on the enclosed response form. On 04/19/2022, the firm extended the recall to two additional lots. The recall notification was sent to the consignees via email with a request for all affected product to be returned.
Quantity in commerce: 9 units
Distribution: US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Product codes and lots: Model: 6101-22200818; Lot: 2022010035; UDI: 00840097501598

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1028-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1026-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-11	2022-04-29
Z-1027-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-11	2022-04-29
Z-1028-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-11	2022-04-29

Product code LXH

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)