Medical DeviceNov 20, 2019
TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD recall — FDA Z-0359-2020
The WHD/WHV impactors can rust over time due to an improper manufacturing process.
Class IIFDA: OngoingTriMed Inc.
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 27
Records are ordered by the best available source date.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI recall — FDA Z-0396-2020
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
Exactech 2.4mm x 2.5 Fluted Pin Pouch recall — FDA Z-0361-2020
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 20, 2019
Avanos Medical CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG recall — FDA Z-0370-2020
The connector piece to the PEG tube does not pass over the guidewire.
Class IIFDA: TerminatedAvanos Medical, Inc.
Medical DeviceNov 20, 2019
Smiths Medical ASD ProtectIV Plus Safety IV Catheter, sterile recall — FDA Z-0352-2020
Certain lots of the Model 306701 ProtectIV Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG recall — FDA Z-0392-2020
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: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533 recall — FDA Z-0402-2020
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
Avanos Medical CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG recall — FDA Z-0371-2020
The connector piece to the PEG tube does not pass over the guidewire.
Class IIFDA: TerminatedAvanos Medical, Inc.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM recall — FDA Z-0386-2020
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
TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) recall — FDA Z-0366-2020
The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully…
Class IIFDA: TerminatedTriMed Inc.
Medical DeviceNov 20, 2019
Carroll-Baccari Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin recall — FDA Z-0368-2020
Product has the potential to be contaminated with Burholderia cepacia.
Class IIFDA: TerminatedCarroll-Baccari, Inc.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non recall — FDA Z-0373-2020
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: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY recall — FDA Z-0393-2020
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: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI recall — FDA Z-0397-2020
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: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI recall — FDA Z-0399-2020
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: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI recall — FDA Z-0389-2020
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 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED recall — FDA Z-0381-2020
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
Tornier Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B recall — FDA Z-0405-2020
During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may…
Class IIFDA: TerminatedTornier, Inc.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI recall — FDA Z-0401-2020
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 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK recall — FDA Z-0380-2020
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
Basic Reset Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B) recall — FDA Z-0348-2020
FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.
Class IIFDA: CompletedBasic Reset Inc.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY recall — FDA Z-0376-2020
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: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY recall — FDA Z-0395-2020
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 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY recall — FDA Z-0377-2020
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.