Device product
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A
Z-1809-2025
Product summary
- Event
- Event 96821
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1853 total
- Official record key
device-enforcement:Z-1809-2025
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 ADD A PACK, SKU DYNJ30926O, UDI-DI 10195327539153 (EA), 40195327539154 (CASE) KIT LOTS 24AMF811 2. CRANIOTOMY, SKU CDS983611N, UDI-DI 10195327466626 (EA), 40195327466627 (CASE) KIT LOTS 23KBA720 23LBI611 23LBJ586 3. CRANIOTOMY CDS, SKU CDS983467J, UDI-DI 10195327561116 (EA), 40195327561117 (CASE) KIT LOTS 24ADA818 24ADC216 24BDA929 24DDB447 24EDA275 24EDA751 24GDB213 24IDA327 24IDB043 4. CRANIOTOMY PACK, SKU DYNJ85807A, UDI-DI 10195327637392 (EA), 40195327637393 (CASE) KIT LOTS 24CBB843 24EBC889 24GBY029 ; SKU DYNJ85927, UDI-DI 10195327575571 (EA), 40195327575572 (CASE) KIT LOTS 24BMD310 24EMI836 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A UDI-DI 10195327635466 (EA), 40195327635467 (CASE) KIT LOTS 24CMA496 24HMI081 24HMI978
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.