| 2023-08-29 |
Class II
|
Ongoing |
Z-0074-2024 |
Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary… |
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Device is breaking while in use, potential for patients to require a revision surgery. |
| 2021-11-02 |
Class II
|
Terminated |
Z-0448-2022 |
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue R… |
— |
Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may … |
| 2021-09-03 |
Class II
|
Terminated |
Z-0034-2022 |
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 |
— |
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced) |
| 2021-09-01 |
Class II
|
Terminated |
Z-0114-2022 |
Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the… |
— |
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| 2021-09-01 |
Class II
|
Terminated |
Z-0113-2022 |
Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be… |
— |
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| 2021-09-01 |
Class II
|
Terminated |
Z-0112-2022 |
Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Fl… |
— |
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| 2021-09-01 |
Class II
|
Terminated |
Z-0111-2022 |
Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been c… |
— |
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| 2021-04-15 |
Class II
|
Terminated |
Z-1698-2021 |
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to inse… |
— |
Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from … |
| 2020-07-08 |
Class II
|
Terminated |
Z-2787-2020 |
Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixat… |
— |
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium… |
| 2020-07-08 |
Class II
|
Terminated |
Z-2786-2020 |
Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixa… |
— |
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium… |
| 2020-07-08 |
Class II
|
Terminated |
Z-2785-2020 |
Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixat… |
— |
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium… |
| 2020-07-08 |
Class II
|
Terminated |
Z-2784-2020 |
Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixati… |
— |
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium… |
| 2020-07-08 |
Class II
|
Terminated |
Z-2783-2020 |
Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixat… |
— |
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium… |
| 2020-07-08 |
Class II
|
Terminated |
Z-2782-2020 |
Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixati… |
— |
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium… |