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-2855-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x36, 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-2870-2020September 2, 2020Audubon, PA
Globus Medical, Inc.
Class IITerminated
ALTERA Spacer ALTERA Spacer, 10x36, 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-2866-2020September 2, 2020Audubon, PA
NOBEL BIOCARE SERVICES AG
Class IITerminated
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supportin...
Reason: Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead...
Z-2828-2020August 26, 2020Kloten, N/A
Neocis Inc.
Class IITerminated
DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phas...
Reason: The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Z-2637-2020July 22, 2020Miami, FL
Neocis Inc.
Class IITerminated
DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phas...
Reason: The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Z-2638-2020July 22, 2020Miami, FL
Neocis Inc.
Class IITerminated
DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phase...
Reason: The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Z-2639-2020July 22, 2020Miami, FL
Bausch & Lomb Surgical, Inc.
Class IITerminated
enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correct...
Reason: The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
Z-2552-2020July 22, 2020Clearwater, FL
OrthoPediatrics Corp
Class IITerminated
OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction ...
Reason: ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in t...
Z-2538-2020July 15, 2020Warsaw, IN
OrthoPediatrics Corp
Class IITerminated
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction ...
Reason: ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in t...
Z-2539-2020July 15, 2020Warsaw, IN
Zest Anchors LLC
Class IIOngoing
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Reason: The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.
Z-2425-2020July 1, 2020Carlsbad, CA
Stryker GmbH
Class IITerminated
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabil...
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2381-2020June 24, 2020Selzach
Stryker GmbH
Class IITerminated
Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of...
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2377-2020June 24, 2020Selzach
Stryker GmbH
Class IITerminated
Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabil...
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2380-2020June 24, 2020Selzach
Stryker GmbH
Class IITerminated
Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stab...
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2379-2020June 24, 2020Selzach
Medtronic Sofamor Danek USA Inc
Class IITerminated
Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessa...
Reason: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may incre...
Z-2390-2020June 24, 2020Memphis, TN
Stryker GmbH
Class IITerminated
Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization o...
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2373-2020June 24, 2020Selzach
Stryker GmbH
Class IITerminated
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabiliz...
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2385-2020June 24, 2020Selzach
Stryker GmbH
Class IITerminated
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabiliz...
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2386-2020June 24, 2020Selzach
Stryker GmbH
Class IITerminated
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabiliz...
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2382-2020June 24, 2020Selzach
Stryker GmbH
Class IITerminated
Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2387-2020June 24, 2020Selzach
Stryker GmbH
Class IITerminated
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabil...
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2383-2020June 24, 2020Selzach
Medtronic Sofamor Danek USA Inc
Class IITerminated
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the neces...
Reason: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may incre...
Z-2389-2020June 24, 2020Memphis, TN
Stryker GmbH
Class IITerminated
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bo...
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2374-2020June 24, 2020Selzach
Medtronic Sofamor Danek USA Inc
Class IITerminated
Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessa...
Reason: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may incre...