Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 25 of 125

Biomet, Inc.

Class II Ongoing

G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462

Reason: The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.

Z-1284-2023 March 29, 2023 Warsaw, IN

DePuy Orthopaedics, Inc.

Class II Ongoing

Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312

Reason: The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of thes...

Z-1266-2023 March 29, 2023 Warsaw, IN

DePuy Orthopaedics, Inc.

Class II Ongoing

Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507

Reason: The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of thes...

Z-1267-2023 March 29, 2023 Warsaw, IN

DePuy Orthopaedics, Inc.

Class II Ongoing

Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118

Reason: The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of thes...

Z-1263-2023 March 29, 2023 Warsaw, IN

DePuy Orthopaedics, Inc.

Class II Ongoing

Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226

Reason: The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of thes...

Z-1265-2023 March 29, 2023 Warsaw, IN

DePuy Orthopaedics, Inc.

Class II Ongoing

Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212

Reason: The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of thes...

Z-1264-2023 March 29, 2023 Warsaw, IN

St. Jude Medical

Class II Ongoing

CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart fai...

Reason: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model...

Z-1219-2023 March 15, 2023 Atlanta, GA

St. Jude Medical

Class II Ongoing

CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart fai...

Reason: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model...

Z-1220-2023 March 15, 2023 Atlanta, GA

St. Jude Medical

Class II Ongoing

CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart fai...

Reason: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model...

Z-1218-2023 March 15, 2023 Atlanta, GA

St. Jude Medical

Class II Ongoing

CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart fa...

Reason: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model...

Z-1221-2023 March 15, 2023 Atlanta, GA

Encore Medical, LP

Class II Ongoing

EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNE...

Reason: Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the su...

Z-1187-2023 March 8, 2023 Austin, TX

Covidien, LP

Class II Ongoing

Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3

Reason: Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of imp...

Z-1183-2023 March 8, 2023 North Haven, CT

Draeger Medical, Inc.

Class I Ongoing

NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)

Reason: The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

Z-1137-2023 March 1, 2023 Telford, PA

Draeger Medical, Inc.

Class I Ongoing

NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)

Reason: The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

Z-1138-2023 March 1, 2023 Telford, PA

MEDLINE INDUSTRIES, LP - Northfield

Class II Ongoing

Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART...

Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Z-1067-2023 February 15, 2023 Northfield, IL

MEDLINE INDUSTRIES, LP - Northfield

Class II Ongoing

Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ...

Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Z-1079-2023 February 15, 2023 Northfield, IL

MEDLINE INDUSTRIES, LP - Northfield

Class II Ongoing

Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; ...

Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Z-1066-2023 February 15, 2023 Northfield, IL

CooperSurgical, Inc.

Class II Ongoing

BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)

Reason: The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.

Z-1044-2023 February 8, 2023 Trumbull, CT

CoreLink LLC

Class II Terminated

CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

Reason: Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.

Z-0954-2023 January 18, 2023 Fenton, MO

Windstone Medical Packaging, Inc.

Class II Ongoing

Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Kne...

Reason: Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.

Z-0881-2023 January 11, 2023 Billings, MT

ENDO Pharmaceuticals Solutions, Inc.

Class II Ongoing

9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01

Reason: No expiration dates printed on the packaging

Z-0774-2023 January 11, 2023 Cranbury, NJ

NuVasive Inc

Class II Ongoing

X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.

Reason: Potential that insert will be unable to disengage from the vertebral body replacement device/implant

Z-0738-2023 December 28, 2022 San Diego, CA

Stradis Medical, LLC dba Stradis Healthcare

Class II Ongoing

STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray

Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in...

Z-0493-2023 December 21, 2022 Peachtree Corners, GA

Zimmer, Inc.

Class II Ongoing

NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01

Reason: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher over...

Z-0470-2023 December 21, 2022 Warsaw, IN

Stradis Medical, LLC dba Stradis Healthcare

Class II Ongoing

Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray

Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in...

Z-0494-2023 December 21, 2022 Peachtree Corners, GA