Medical Device Recalls

Medtronic Sofamor Danek USA Inc

Class II Terminated

Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm

Reason: Engraving on implants may not match what is listed on the pouch labels.

Z-0086-2022 October 20, 2021 Memphis, TN

Flower Orthopedics Corporation

Class II Terminated

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 Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foo...

Reason: Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Z-0114-2022 October 20, 2021 Horsham, PA

Flower Orthopedics Corporation

Class II Terminated

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 Flower Small and Medium Implant Set and uses the small locking mechanism. Catalo...

Reason: Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Z-0112-2022 October 20, 2021 Horsham, PA

Medtronic Sofamor Danek USA Inc

Class II Terminated

Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm

Reason: Engraving on implants may not match what is listed on the pouch labels.

Z-0085-2022 October 20, 2021 Memphis, TN

Flower Orthopedics Corporation

Class II Terminated

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 used with any the Flower Small and Medium Implant Set Flower Ankle Plating Se...

Reason: Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Z-0113-2022 October 20, 2021 Horsham, PA

Paltop Advanced Dental Solutions Ltd

Class II Terminated

Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The...

Reason: Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size eng...

Z-0018-2022 October 13, 2021 Caesarea

Johnson & Johnson Surgical Vision Inc

Class II Terminated

TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular ca...

Reason: Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recom...

Z-0028-2022 October 13, 2021 Santa Ana, CA

Paltop Advanced Dental Solutions Ltd

Class II Terminated

Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. Th...

Reason: Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size eng...

Z-0017-2022 October 13, 2021 Caesarea

Paltop Advanced Dental Solutions Ltd

Class II Terminated

Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The ...

Reason: Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size eng...

Z-0013-2022 October 13, 2021 Caesarea

Paltop Advanced Dental Solutions Ltd

Class II Terminated

Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The...

Reason: Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size eng...

Z-0016-2022 October 13, 2021 Caesarea

Paltop Advanced Dental Solutions Ltd

Class II Terminated

Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The...

Reason: Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size eng...

Z-0015-2022 October 13, 2021 Caesarea

Paltop Advanced Dental Solutions Ltd

Class II Terminated

Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The ...

Reason: Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size eng...

Z-0014-2022 October 13, 2021 Caesarea

Aesculap Implant Systems LLC

Class II Terminated

PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU

Reason: Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery

Z-2578-2021 October 6, 2021 Center Valley, PA

Aesculap Implant Systems LLC

Class II Terminated

PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13

Reason: Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery

Z-2579-2021 October 6, 2021 Center Valley, PA

Aesculap Implant Systems LLC

Class II Terminated

Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEME...