Device product
Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
Z-1070-2023
Product summary
- Event
- Event 91386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 174 cases (750 units)
- Official record key
device-enforcement:Z-1070-2023
Official wording
Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Code information: a. ORAL SURGERY PACK-LF, Item Number: DYNJ20491N, Case UDI/GTIN: 40195327024582, Unit UDI/GTIN: 10195327024581, Lot Number: 22IDA002; b. EXTRACTION PACK, Item Number: DYNJ49329F, Case UDI/GTIN: 40195327059638, Unit UDI/GTIN: 10195327059637, Lot Number: 22HBR730; c. ORAL SURGERY PACK, Item Number: DYNJ52404G, Case UDI/GTIN: 40195327222612, Unit UDI/GTIN: 10195327222611, Lot Number: 22IDA539,22HDB737; d. DENTAL MINOR PACK, Item Number: DYNJ83140, Case UDI/GTIN: 40195327232956, Unit UDI/GTIN: 10195327232955, Lot Number: 22JBN386; e. ORAL, Item Number: DYNJ902377G, Case UDI/GTIN: 40195327224746, Unit UDI/GTIN: 10195327224745, Lot Number: 22KBG529,22JBO834;
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Derived failure modes
-
Unknown
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.