FDAFebruary 4, 2015device
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
What to do
FDA enforcement status: Terminated
Brands named
materialise n vmaterialise
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.1012023-06-19
- FDAMRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-012023-04-26
- FDAProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.2082022-07-13
- FDAMatch Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-...2020-07-17
- FDATRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.0012020-02-03
- FDATRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.0132020-02-03
- FDASignature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.2016-05-03
- FDASignature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.2015-09-23
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