Medical DeviceNov 20, 2019
Synthes (USA) Products MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm recall — FDA Z-0349-2020
Modified outside of approved manufacturing process
Class IIFDA: TerminatedSynthes (USA) Products LLC
Monthly breakdown
2019 recalls by month
Select a month to review the recall records reported during that period.
December 2019321 records · 4 categoriesNovember 2019597 records · 4 categoriesOctober 2019525 records · 4 categoriesSeptember 2019268 records · 4 categoriesAugust 2019505 records · 4 categoriesJuly 2019680 records · 4 categoriesJune 2019445 records · 4 categoriesMay 2019396 records · 4 categoriesApril 2019242 records · 4 categoriesMarch 2019250 records · 4 categoriesFebruary 2019381 records · 4 categoriesJanuary 2019142 records · 4 categories
2019 recalls — page 28
Records are ordered by the best available source date.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK recall — FDA Z-0384-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform recall — FDA Z-0364-2020
A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
Class IIFDA: TerminatedImplant Direct Sybron Manufacturing, LLC
Medical DeviceNov 20, 2019
Heritage Medical Products 2000 Vascular with 30 Degree option recall — FDA Z-0353-2020
Potential for bed to drop suddenly at the head while a patient is laying on it.
Class IIFDA: TerminatedHeritage Medical Products, Inc.
Medical DeviceNov 20, 2019
Smith & Nephew LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN recall — FDA Z-0351-2020
LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not…
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI recall — FDA Z-0394-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
Carroll-Baccari Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin recall — FDA Z-0369-2020
Product has the potential to be contaminated with Burholderia cepacia.
Class IIFDA: TerminatedCarroll-Baccari, Inc.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922 recall — FDA Z-0400-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
Tec Com Gmbh TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse recall — FDA Z-0362-2020
The action is being initiated due to potential installation of faulty peltier-elements within the thermo-regulation system. Failure of the peltier-element would report a system failure and…
Class IIFDA: TerminatedTec Com Gmbh
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT recall — FDA Z-0398-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO recall — FDA Z-0391-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non recall — FDA Z-0374-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK recall — FDA Z-0385-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656 recall — FDA Z-0403-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
Canon Medical System, USA Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table recall — FDA Z-0360-2020
Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.
Class IIFDA: TerminatedCanon Medical System, USA, Inc.
Medical DeviceNov 20, 2019
TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx recall — FDA Z-0357-2020
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Class IIFDA: OngoingTriMed Inc.
Medical DeviceNov 20, 2019
RANDOX NEFA recall — FDA Z-0367-2020
Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.
Class IIIFDA: TerminatedRandox Laboratories, Limited
Medical DeviceNov 20, 2019
TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx recall — FDA Z-0356-2020
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Class IIFDA: OngoingTriMed Inc.
Medical DeviceNov 20, 2019
Galil Medical Visual-ICE Cryoablation System, FPRCH6000 recall — FDA Z-0404-2020
Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance.
Class IIFDA: TerminatedGalil Medical, Inc.
Medical DeviceNov 20, 2019
TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx recall — FDA Z-0358-2020
The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.
Class IIFDA: OngoingTriMed Inc.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY recall — FDA Z-0375-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non recall — FDA Z-0379-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
Siemens Medical Solutions USA Software versions syngo CT VB20 running on the following recall — FDA Z-0406-2020
Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX recall — FDA Z-0387-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
About the 2019 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.