Z-0927-2023 Class II Terminated
FDA device recall Z-0927-2023 was initiated by DeRoyal Industries Inc on Dec 12, 2022 and is designated Class II. Reason for recall: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging… The recall status is terminated (terminated May 29, 2026). Affected quantity: 157 packs.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 18, 2023
- Initiation Date
- Dec 12, 2022
- Termination Date
- May 29, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 157 packs
Product Description
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Reason for Recall
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
Distribution Pattern
US Nationwide distribution in the states of IL, MO.
Code Information
a) REF 89-9004.09, GTIN 00749756903936, Lot Numbers: 57391129 exp 5/1/2023, 57755421 exp 5/1/2023, 57900931 exp 5/1/2023 b) REF 89-9004.10, GTIN 00749756903931, Lot Numbers: 57913767 exp 5/1/2023
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0927-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026