Device product
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A 5. CRANIOTOMY CDS SKU CDS981888X CDS983467I 6. CRANIOTOMY PACK-LF SKU DYNJ09882G DYNJ09882I 7. CRANIOTOMY S NASSAU SKU DYNJ905879G 8. MHC CRANIOTOMY SKU DYNJ903713K DYNJ903713L 9. PAD CRANIOTOMY SKU DYNJ902149J
Z-1811-2025
Product summary
- Event
- Event 96821
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1,853 total
- Official record key
device-enforcement:Z-1811-2025
Official wording
Reason: Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Code information: 1. CRANI ACCESSORY PACK SKU DYNJ59270 UDI-DI 10888277771512 (ea), 40888277771513 (case) Lots 23JDB683 23JDC548 24ADB783 24HDA822 2. CRANI PACK-LF SKU DYNJ44805M UDI-DI 10195327506872 (ea), 40195327506873 (case) Lots 23JBI747 23KBL228 24ABG696 24CBM117 24EBQ114 24GBJ699 3. CRANIOTOMY SKU CDS982719V UDI-DI 10195327510831 (ea), 40195327510832 (case) Lots 23KBP461 23LBN381 24ABB119 24BBC547 24BBI145 SKU CDS982719W UDI-DI 10195327645090 (ea), 40195327645091 (case) Lots 24DBS813 SKU DYNJ904168F UDI-DI 10195327395728 (ea), 40195327395729 (case) Lots 24DBU188 SKU DYNJ908404B UDI-DI 10195327410506 (ea), 40195327410507 (case) Lots 23IDB680 23LDB546 24BDB174 24FDA741 24FDB584 24IDA225 24IDA646 24IDA840 SKU DYNJ908723A UDI-DI 10195327403270 (ea), 40195327403271 (case) Lots 23IBO314 23JBC218 24ABK090 SKU DYNJ908723C UDI-DI 10198459009785 (ea), 40198459009786 (case) Lots 24IBM205 24IBN365 25ABM356 4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A UDI-DI 10195327466466 (ea), 40195327466467 (case) Lots 23JLA765 24DLA724 24DLB006 24ELA325 5. CRANIOTOMY CDS SKU CDS981888X UDI-DI 10195327144760 (ea), 40195327144761 (case) Lots 24ABT432 24CBD698 24HBH954 24HBP483 24IBG797 25CBF098 SKU CDS983467I UDI-DI 10195327457945 (ea), 40195327457946 (case) Lots 23KDA336 6. CRANIOTOMY PACK-LF SKU DYNJ09882G UDI-DI 10195327574055 (ea), 40195327574056 (case) Lots 24CBF778 SKU DYNJ09882I UDI-DI 10198459058172 (ea), 40198459058173 (case) Lots 24HBN426 7. CRANIOTOMY S NASSAU SKU DYNJ905879G UDI-DI 10195327512996 (ea), 40195327512997 (case) Lots 23KBI086 23LBH647 23LBH649 24BBU253 24DBV133 24FBE409 8. MHC CRANIOTOMY SKU DYNJ903713K UDI-DI 10195327201579 (ea), 40195327201570 (case) Lots 23JBK426 SKU DYNJ903713L UDI-DI 10195327531218 (ea), 40195327531219 (case) Lots 23KBT939 23LBS862 24ABH577 24CBH126 24CBH771 9. PAD CRANIOTOMY SKU DYNJ902149J UDI-DI 10195327554323 (ea), 40195327554324 (case) Lots 23KBP275 24ABJ684 24CBF216 24DBI296 24EBD959 24FBF064 24HBK164 24IBN443
Distribution pattern: US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.
Derived failure modes
-
Unknown
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.