Signature 42-422551Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI E314424225510), received between Jan 11, 2017 and Nov 28, 2017 — classified as 2 injuries.

4 other recalls cover devices cleared under the same FDA submission (K102795); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT SPECIFIC GUIDE WAS USED TO PLACE A TOTAL KNEE REPLACEMENT IMPLANT IN (B)(6) 2013. PATIENT WAS REVISED DUE TO MALALIGNMENT OF TIBIAL AND FEMORAL COMPONENTS IN (B)(6) 2017.

  Patient problems: No Code Available

  MAUDE report 7062930 ↗
• InjuryJan 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT SPECIFIC GUIDE WAS USED TO PLACE A TOTAL KNEE REPLACEMENT IMPLANT. THE GUIDE FIT WAS GOOD BUT THE RESULTING DISTAL FEMORAL CUT WAS IN APPROXIMATELY 15 DEGREES OF FLEXION. AT THIS STAGE THE USE OF THE GUIDES WAS ABANDONED AND STANDARD INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE. POSTOPERATIVE X-RAY SHOWS A WELL ALIGNED FEMORAL COMPONENT WITH CEMENT IN THE REGION OF THE POSTERIOR CHAMFER.

  Patient problems: No Code Available

  MAUDE report 6241064 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102795. One submission often covers many models, so check the product and lot details in each record.

• Z-1941-2016 · May 3, 2016 · Terminated
  Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
• Z-0162-2016 · Sep 23, 2015 · Terminated
  Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Pe
• Z-1287-2015 · Feb 4, 2015 · Terminated
  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. L
• Z-1145-2012 · Aug 4, 2011 · Terminated
  REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis, knee) SET 04-05 DGHUMPHR-NOV52LKA-J_K-00432022 SLIDEX DISTAL-MP/PREMIER TIBIAL CUSTOM-MADE DEVICE Signature Personalized Pa