Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-2311-2009 | Bone Screw 7MM (D) x 35 MM (L) Telescopic Plate Spacer Thoracolumbar Spinal System; Made... | Ebi, LLC | MQP | ||
| Z-2310-2009 | Bone Screw 6MM (D) x 35MM (L) Telescopic Plate Spacer, Thoracolumbar Spinal System Made... | Ebi, LLC | MQP | ||
| Z-2309-2009 | Fixed Closed Screw (Ti); 6.0MM (D) x 40 MM (L) Made In USA, Biomet Spine, Parsippany... | Ebi, LLC | MNI | ||
| Z-2308-2009 | Fixed Closed Screw (Ti); 5.0MM (D) x 25MM (L); Made in USA, Biomet Spine, Parsippany... | Ebi, LLC | MNH | ||
| Z-2307-2009 | Fixed Open Screw (TI); 7.0MM (D) x 30MM (L); Made In USA, Biomet Spine, Parsippany, NJ... | Ebi, LLC | MNH | ||
| Z-2306-2009 | Fixed Closed Screw, 6.5mm (D) x 40mm (L), Made in USA; Biomet Spine, Parsippany... | Ebi, LLC | MNH | ||
| Z-1539-2009 | Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R... | C.R. Bard Inc | FPA | ||
| Z-1416-2009 | Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush)... | Cook Ob/Gyn | HFE | ||
| Z-1642-2009 | Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog... | Howmedica Osteonics Corp | LZO | ||
| Z-2305-2009 | Pediatric Femoral Nail 5.5MM (d) x 36 CM (L) Rx only, Sterile; Biomet, 100 Interpace... | Ebi, LLC | HSB | ||
| Z-2304-2009 | Pediatric Femoral Nail 5.5MM (d) x 32 CM (L) Rx only, Sterile; Biomet, 100 Interpace... | Ebi, LLC | HSB | ||
| Z-2303-2009 | Pediatric Femoral Nail 5.5MM (d) x 30 CM (L) Rx only, Sterile; Biomet, 100 Interpace... | Ebi, LLC | HSB | ||
| Z-2302-2009 | Pediatric Femoral Nail 5.5MM (d) x 28 CM (L) Rx only, Sterile; Biomet, 100 Interpace... | Ebi, LLC | HSB | ||
| Z-2301-2009 | C-Tek Maxan Anterior Cervical Plate System; 4.0MM X 20MM Fixed Screw' Biomet Spine, 100... | Ebi, LLC | HSB | ||
| Z-2300-2009 | Cannulated Screw Ballista Percutaneous Pedicle Screw System. 6/5 x 45MM; Biomet Spine... | Ebi, LLC | HSB | ||
| Z-2299-2009 | Bone Screw4.5MM X 95MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway... | Ebi, LLC | HSB | ||
| Z-2298-2009 | Bone Screw 4.5MM X 70MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway... | Ebi, LLC | HSB | ||
| Z-2297-2009 | Bone Screw .5MM X 60MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway... | Ebi, LLC | HSB | ||
| Z-2296-2009 | Bone Screw 4.5MM X 52MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway... | Ebi, LLC | HSB | ||
| Z-2295-2009 | Bone Screw 4.5MM X 36MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway... | Ebi, LLC | HSB | ||
| Z-2294-2009 | Bone Screw 4.5MM X 28MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway... | Ebi, LLC | HSB | ||
| Z-2293-2009 | Bone Screw 4.5MM X 20MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway... | Ebi, LLC | HSB | ||
| Z-2292-2009 | Bone Screw 5.5MM X 70MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway... | Ebi, LLC | HSB | ||
| Z-2291-2009 | Bone Screw 5.5MM X 55MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway... | Ebi, LLC | HSB | ||
| Z-2290-2009 | Bone Screw 5.5MM X 45MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway... | Ebi, LLC | HSB | ||
| Z-2289-2009 | TI Screw Buttress Thread 6MM (D) x 65MM (L) Trauma Fixation Systems, Rx Only; Biomet... | Ebi, LLC | HSB | ||
| Z-2288-2009 | TI Screw Buttress Thread 5MM (D) x 35MM (L) Trauma Fixation Systems, Rx Only; Biomet... | Ebi, LLC | HSB | ||
| Z-2287-2009 | TI Cannulated Screw 32MM thrd 7.3MM (d) X 120MM (L); Trauma Fixation Systems, Rx... | Ebi, LLC | HSB | ||
| Z-2286-2009 | TI Cannulated Screw 32MM thrd 7.3MM (d) X 100MM (L); Trauma Fixation Systems, Rx... | Ebi, LLC | HSB | ||
| Z-2285-2009 | TI Cannulated Screw 32MM thrd 7.3MM (d) X 95MM (L); Trauma Fixation Systems, Rx... | Ebi, LLC | HSB | ||
| Z-2284-2009 | TI Cannulated Screw 20MM thrd 6.5MM (d) X 85MM (L); Trauma Fixation Systems, Rx... | Ebi, LLC | HSB | ||
| Z-2283-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 95MM; Trauma Fixation Systems, Rx Only; Biomet... | Ebi, LLC | HSB | ||
| Z-2282-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 90MM; Trauma Fixation Systems, Rx Only; Biomet... | Ebi, LLC | HSB | ||
| Z-2281-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 85MM; Trauma Fixation Systems, Rx Only; Biomet... | Ebi, LLC | HSB | ||
| Z-2280-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 80MM; Trauma Fixation Systems, Rx Only; Biomet... | Ebi, LLC | HSB | ||
| Z-2279-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 75MM; Trauma Fixation Systems, Rx Only; Biomet... | Ebi, LLC | HSB | ||
| Z-2278-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 70MM; Trauma Fixation Systems, Rx Only; Biomet... | Ebi, LLC | HSB | ||
| Z-2277-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 65MM; Trauma Fixation Systems, Rx Only; Biomet... | Ebi, LLC | HSB | ||
| Z-0365-2011 | SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.13, and... | SCC Soft Computer | JQP | ||
| Z-1897-2009 | Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies... | Apheresis Technologies, Inc. | FIR | ||
| Z-0541-2011 | A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient... | A-dec, Inc. | KLC | ||
| Z-1394-2009 | Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules)... | Roche Diagnostics GmbH | JQP | ||
| Z-1393-2009 | Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules)... | Roche Diagnostics GmbH | JQP | ||
| Z-0811-2010 | Biphasic LIFEPAK 12 defibrillator / monitor. | Physio Control, Inc. | MKJ | ||
| Z-1816-2009 | Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System... | Abbott Medical | frn | ||
| Z-1815-2009 | Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System... | Abbott Medical | frn | ||
| Z-1353-2009 | Biomet Dual Offset Broach Handle, Clamping Style, Right, REF 31-555404. For use in... | Zimmer GmbH | LXH | ||
| Z-1352-2009 | Biomet Dual Offset Broach Handle, Clamping Style, Left, REF 31-555403. For use in... | Zimmer GmbH | LXH | ||
| Z-1757-2010 | Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac... | ZOLL Medical Corporation | IOL | ||
| Z-1199-2009 | HeartStart XL Model M4735A Defibrillator, Automatic, External Defibrillator-Monitor... | Philips North America LLC | MKJ |