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Nextremity Solutions Recalls
15 recalls on record · December 4, 2019 to April 20, 2022 · Medical Devices
Recalls by year
19
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22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 20, 2022Medical DevicesFDA
Nextremity Solutions recalls Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
Hazard: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
April 20, 2022Medical DevicesFDA
Nextremity Solutions recalls Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrum
Hazard: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
April 20, 2022Medical DevicesFDA
Nextremity Solutions recalls Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
Hazard: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
April 20, 2022Medical DevicesFDA
Nextremity Solutions recalls Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instru
Hazard: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
April 20, 2022Medical DevicesFDA
Nextremity Solutions recalls Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
Hazard: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
March 16, 2022Medical DevicesFDA
Nextremity Solutions recalls Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital rep
Hazard: During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision
March 16, 2022Medical DevicesFDA
Nextremity Solutions recalls Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repa
Hazard: During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision
May 5, 2021Medical DevicesFDA
Nextremity Solutions recalls InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct in
Hazard: Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
May 5, 2021Medical DevicesFDA
Nextremity Solutions recalls InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct int
Hazard: Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
March 18, 2020Medical DevicesFDA
Nextremity Solutions recalls Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra
Hazard: Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
February 19, 2020Medical DevicesFDA
Nextremity Solutions recalls Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Pla
Hazard: The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
January 15, 2020Medical DevicesFDA
Nextremity Solutions recalls Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
Hazard: Components 2mm shorter than indicated on the package label
January 15, 2020Medical DevicesFDA
Nextremity Solutions recalls Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
Hazard: Components 2mm shorter than indicated on the package label
January 15, 2020Medical DevicesFDA
Nextremity Solutions recalls Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
Hazard: Components 2mm shorter than indicated on the package label
December 4, 2019Medical DevicesFDA
Nextremity Solutions recalls Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Strat
Hazard: Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length