Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to...
Reason: LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits u...
Z-2986-2020September 30, 2020Saluggia, N/A
Sorin Group Italia S.r.l.
Class IITerminated
Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used t...
Reason: LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits u...
Z-2987-2020September 30, 2020Saluggia, N/A
Sorin Group Italia S.r.l.
Class IITerminated
Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to redu...
Reason: LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits u...
Z-2988-2020September 30, 2020Saluggia, N/A
SICAT GMBH & CO. KG
Class IITerminated
SICAT IMPLANT V2.0
Reason: A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.
Z-2951-2020September 16, 2020Bonn
Exactech, Inc.
Class IIOngoing
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Reason: The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed B...
Z-2926-2020September 9, 2020Gainesville, FL
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2857-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2852-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2860-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2854-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2851-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2856-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2859-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2869-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2864-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2871-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2861-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2850-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2862-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2865-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Reason: Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Z-2849-2020September 2, 2020Billerica, MA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2868-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2853-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2858-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿
Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.