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primaLOK FF

Wenzel Spine, Inc. · Model 800-1145-00 · UDI-DI 00813210021990

MRW Prescription

510(k) clearances

105

Adverse events

Recalls

100

Facilities

Description

primaLOK FF 45mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.

Recalls

Date	Firm	Reason
2021-04-27	Medtronic Sofamor Danek USA, Inc	Product is impacted by a thread profile defect due to a manufacturing issue.
2011-06-07	Osteomed, Lp	Two of the Implant Driver Assembly tips were reported to break during surgery.
2011-03-15	Interventional Spine Inc	This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver ra
2011-03-15	Interventional Spine Inc	This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver ra

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.