Zimmer, Inc. - Zimmer Patellofemoral Joint (PFJ) Prosthesis - Class 2 Recall
Gender Solution Patello-Femoral Joint System Patello-Femoral Trochlea Component, Precoat, Size 4, Left Product Usage: The Zimmer Patellofemoral Joint (PFJ) Prosthesis is designed to closely replicate the anatomic features of the patellar groove on the femur. The implant s articulating surface incorporates the NexGen¿ knee system s frontal profile geometry for optimal patella tracking for both resurfaced and unresurfaced patellae. The construct of the PFJ prosthesis accommodates a wide range of patients, both female and male. Five sizes in left and right configurations are being offered for this implant. Intended...
Source: Medical Device Recalls - August 27, 2014 Category: Medical Equipment Source Type: alerts
DeRoyal Industries Inc - DeRoyal (R) KNEE ARTHROSCOPY PACK - Class 2 Recall
DeRoyal (R) KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2014 Category: Medical Equipment Source Type: alerts
DeRoyal Industries Inc - DeRoyal KNEE ARTHROSCOPY PACK - Class 2 Recall
DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2014 Category: Medical Equipment Source Type: alerts
The Anspach Effort, Inc. - Anspach Modified Arthroscopic Knotless Suture Anchor - Class 2 Recall
ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only*** This device is intended to be used with Anspach Systems (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2014 Category: Medical Equipment Source Type: alerts
The Anspach Effort, Inc. - Anspach Arthroscopic Suture Anchor Assembly with Suture Threader - Class 2 Recall
ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only*** This device is intended to be used with Anspach Systems (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2014 Category: Medical Equipment Source Type: alerts
The Anspach Effort, Inc. - Anspach Threaders, Arthroscopic Suture Anchor - Class 2 Recall
ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2014 Category: Medical Equipment Source Type: alerts
The Anspach Effort, Inc. - Anspach Arthroscopic Knotless Suture Anchor - Class 2 Recall
ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2014 Category: Medical Equipment Source Type: alerts
Biomet, Inc. - EZPass Suture Retriever Nitinol Single Pack - Class 2 Recall
Orthopedic Manual Surgical Instrument, Medical Device Listing Number E122920. Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 17, 2014 Category: Medical Equipment Source Type: alerts
Biomet, Inc. - EZPass Passer - Class 2 Recall
EZPass Passer, Medical Device Listing Number D078363. Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 17, 2014 Category: Medical Equipment Source Type: alerts
Biomet, Inc. - EZPass Nylon Monofilament Single Pack - Class 2 Recall
EZPass Orthopedic Manual Surgical Instrument Medical Device Listing Number E122920. Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 17, 2014 Category: Medical Equipment Source Type: alerts
DePuy Mitek, Inc., a Johnson & Johnson Co. - DePuy Mitek FMS Outflow Tubing with OneWay valve - Class 2 Recall
DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 2013 Category: Medical Equipment Source Type: alerts
DePuy Mitek, Inc., a Johnson & Johnson Co. - DePuy Mitek FMS Intermediary Tubing with OneWay valve - Class 2 Recall
DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Intermediary Tubing is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy . (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 2013 Category: Medical Equipment Source Type: alerts
Baxter Healthcare Corp. - Four Lead TUR Irrigation Set, UROMATIC Plastic Contaners. - Class 2 Recall
Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2013 Category: Medical Equipment Source Type: alerts
Baxter Healthcare Corp. - Two Lead TUR Irrigation Set - Class 2 Recall
Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2013 Category: Medical Equipment Source Type: alerts
Baxter Healthcare Corp. - Four Lead Arthroscopic irrigation Set, for use with ARTROMATIC Plastic Containers. - Class 2 Recall
Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2013 Category: Medical Equipment Source Type: alerts
