Browse Device Recalls
93 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 93 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 93 FDA device recalls in 2009.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Spinal Elements, Inc |
| Apr 13, 2009 | Sunquest Encompass The reporting site is using the Encompass software in a... | Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect ... | Class III | Sunquest Information Systems, Inc. |
| Apr 6, 2009 | Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring ... | The firm is initiating this recall because the implied or stated indications in their labeling as... | Class II | Stellate Systems |
| Mar 6, 2009 | Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS... | Incorrect thread form on the screw. | Class II | Exactech, Inc. |
| Mar 4, 2009 | lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014... | Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the ... | Class II | Invatec Llc |
| Jan 25, 2009 | IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscula... | Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to op... | Class II | Zynex Medical, Inc. |
| Jan 5, 2009 | Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.