510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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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

59,476 records, page 974 of 1190
FDA device recalls, page 974 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1360-2009Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper...Howmedica Osteonics CorpMEH
Z-1359-2009Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper...Howmedica Osteonics CorpMEH
Z-1358-2009Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper...Howmedica Osteonics CorpMEH
Z-1357-2009Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper...Howmedica Osteonics CorpMEH
Z-1356-2009Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper...Howmedica Osteonics CorpMEH
Z-1355-2009Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper...Howmedica Osteonics CorpMEH
Z-1354-2009Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper...Howmedica Osteonics CorpMEH
Z-0999-2009Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of...Medtronic, Inc.IYN
Z-0998-2009Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of...Medtronic, Inc.IYN
Z-0378-2013Class II7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0377-2013Class II7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0376-2013Class II7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0375-2013Class II6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0374-2013Class II6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0373-2013Class II6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0372-2013Class II5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0371-2013Class II5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0370-2013Class II5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0369-2013Class II4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0368-2013Class II4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0367-2013Class IIScrew Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0366-2013Class II7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0365-2013Class II7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0364-2013Class II7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0363-2013Class II7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0362-2013Class II7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0361-2013Class II7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0360-2013Class II6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0359-2013Class II6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0358-2013Class II6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0357-2013Class II6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0356-2013Class II6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0355-2013Class II6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0354-2013Class II5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0353-2013Class II5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0352-2013Class II5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0351-2013Class II5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0350-2013Class II5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0349-2013Class II5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-0348-2013Class IIScrew Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNINuVasive IncNKB
Z-1399-2009Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number...Siemens Healthcare Diagnostics Inc.DGC
Z-0943-2009Stryker InTouch 1.0 Zoom Critical Care Bed (Model 2140) with the Integrated PositionPro...Stryker MedicalFNL
Z-0942-2009Stryker InTouch 1.0 Critical Care Bed (Model 2130) with the Integrated PositionPro...Stryker MedicalFNL
Z-0941-2009Stryker InTouch 1.0 Zoom Critical Care Bed; Model 2140. The device is intended to be...Stryker MedicalFNL
Z-0940-2009Stryker InTouch 1.0 Critical Care Bed; Model 2130. The device is intended to be used...Stryker MedicalFNL
Z-1620-2011BD FACS Sample Prep Assistant (SPA and SPA II) Instrument, Model Number: 334080, Product...Becton, Dickinson and Company, BD BiosciencesJQW
Z-0260-2012Product is a synthetic absorbable suture with needle and labeled as sterile. The product...C P Medical Inc.GAM
Z-0259-2012Product is a synthetic absorbable suture with needle and labeled as sterile. The product...C P Medical Inc.NEW
Z-0033-2011SpeedLink 6.0 Transverse Connector X-Long 60-75mm, non-sterile, 1304-60XLZimmer GmbHKWP
Z-0032-2011SpeedLink 6.0 Transverse Connector Long 50-60mm, non-sterile, 1304-60LZimmer GmbHKWP