Z-0488-2023Class II

STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray

Name: Z-0488-2023 STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
Creator: Stradis Medical, LLC dba Stradis Healthcare
Published: 2022-11-02
License: https://open.fda.gov/license/

Gyn-Disposables, Inc. / initiated 2022-11-02 / Open, Classified / root cause: packaging

FDA source

Stradis Medical, LLC dba Stradis Healthcare began a recall of STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray on 2022-11-02. FDA classified it as Class II and gives the reason as "Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0488-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-02
Posted: 2022-12-14
Recalling firm: Gyn-Disposables, Inc.
Product: STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
Product code: PWL Oral Surgery Tray
Reason for recall: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at [email protected]. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Quantity in commerce: 20 units
Distribution: US nationwide distribution, and Canada.
Product codes and lots: UDI/DI (case) M75240561BIP1, UDI/DI (kit)M75240561BIP0, Serial/Lot Numbers: 22228490663, 22242491516, 22242491516

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0488-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0481-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0482-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0483-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0484-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0485-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0486-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0487-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0488-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0489-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0490-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0491-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0492-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0493-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0494-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0495-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0496-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0497-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0498-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0499-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0500-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0501-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0502-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0503-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0504-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0505-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0506-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0507-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0508-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0509-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0510-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0511-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0512-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0513-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0514-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0515-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0516-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0517-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0518-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0519-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0520-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0521-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0522-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0523-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0524-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0525-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0526-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0527-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0528-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0529-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0530-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0531-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0532-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0533-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0534-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0535-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0536-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0537-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0538-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0539-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0540-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0541-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0542-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0543-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0544-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0545-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0546-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0547-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0548-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0549-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0550-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0551-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0552-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0553-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0554-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0555-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0556-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0557-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14
Z-0558-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14

Product code PWL

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)