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-1428-2015 | Class II | NobelReplace CC RP 4.3x8mm, Article No. 36704. | Nobel Biocare USA LLC | DZE | |
| Z-1427-2015 | Class II | NobelReplace CC NP 3.5x13mm, Article No. 36702. | Nobel Biocare USA LLC | DZE | |
| Z-1426-2015 | Class II | NobelReplace CC NP 3.5x11.5mm, Article No. 36701. | Nobel Biocare USA LLC | DZE | |
| Z-1425-2015 | Class II | NobelReplace CC NP 3.5x10mm, Article No. 36700. | Nobel Biocare USA LLC | DZE | |
| Z-1424-2015 | Class II | Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107. | Nobel Biocare USA LLC | DZE | |
| Z-1423-2015 | Class II | Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's Dental... | Nobel Biocare USA LLC | DZE | |
| Z-1422-2015 | Class II | NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Dental Implants... | Nobel Biocare USA LLC | DZE | |
| Z-1421-2015 | Class II | NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's Dental Implants... | Nobel Biocare USA LLC | DZE | |
| Z-1420-2015 | Class II | NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental... | Nobel Biocare USA LLC | DZE | |
| Z-1419-2015 | Class II | NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's Dental... | Nobel Biocare USA LLC | DZE | |
| Z-1418-2015 | Class II | Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424. Nobel Biocare's Dental... | Nobel Biocare USA LLC | DZE | |
| Z-1417-2015 | Class II | Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423. Nobel Biocare's Dental... | Nobel Biocare USA LLC | DZE | |
| Z-1416-2015 | Class II | Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. Nobel Biocare's Dental... | Nobel Biocare USA LLC | DZE | |
| Z-1415-2015 | Class II | Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's Dental... | Nobel Biocare USA LLC | DZE | |
| Z-1511-2015 | Class II | TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown... | Specialty Appliances, LLC | ECN | |
| Z-1510-2015 | Class II | Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk) A... | Specialty Appliances, LLC | ECN | |
| Z-1509-2015 | Class II | TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR... | Specialty Appliances, LLC | ECN | |
| Z-1508-2015 | Class II | LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/pk) A Herbst... | Specialty Appliances, LLC | ECN | |
| Z-1507-2015 | Class II | HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH... | Specialty Appliances, LLC | ECN | |
| Z-1506-2015 | Class II | M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect... | Specialty Appliances, LLC | ECN | |
| Z-1505-2015 | Class II | Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and... | Specialty Appliances, LLC | ECN | |
| Z-1504-2015 | Class II | TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herbst... | Specialty Appliances, LLC | ECN | |
| Z-1503-2015 | Class II | MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A... | Specialty Appliances, LLC | ECN | |
| Z-1450-2015 | Class II | WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with... | CooperSurgical, Inc. | GEH | |
| Z-1414-2015 | Class II | Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental... | Nobel Biocare USA LLC | DZE | |
| Z-1502-2015 | Class II | Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to... | Specialty Appliances, LLC | ECN | |
| Z-1441-2015 | Class II | Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray... | GE Healthcare | KPY | |
| Z-1396-2015 | Class II | Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert... | Xtant Medical Holdings, Inc. | LXH | |
| Z-1319-2015 | Class II | DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant. | In2Bones SAS | HWC | |
| Z-1318-2015 | Class II | DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant. | In2Bones SAS | HWC | |
| Z-1308-2015 | Class II | MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use... | Siemens Medical Solutions USA, Inc. | LNH | |
| Z-1305-2015 | Class II | GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH... | GE Healthcare | LNH | |
| Z-1793-2015 | Class II | Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory devices)... | Philips North America LLC | JAK | |
| Z-1792-2015 | Class II | BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography... | Philips North America LLC | KPS | |
| Z-1791-2015 | Class II | BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | KPS | |
| Z-1790-2015 | Class II | BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography... | Philips North America LLC | KPS | |
| Z-1789-2015 | Class II | GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | KPS | |
| Z-1788-2015 | Class II | GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | KPS | |
| Z-1787-2015 | Class II | GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | KPS | |
| Z-1786-2015 | Class II | GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | KPS | |
| Z-1785-2015 | Class II | Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography... | Philips North America LLC | KPS | |
| Z-1784-2015 | Class II | CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography... | Philips North America LLC | KPS | |
| Z-1783-2015 | Class II | TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices)... | Philips North America LLC | KPS | |
| Z-1782-2015 | Class II | Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | KPS | |
| Z-1781-2015 | Class II | Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | KPS | |
| Z-1780-2015 | Class II | Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | OUO | |
| Z-1779-2015 | Class II | Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography... | Philips North America LLC | KPS | |
| Z-1778-2015 | Class II | Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography... | Philips North America LLC | KPS | |
| Z-1777-2015 | Class II | Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | KPS | |
| Z-1776-2015 | Class II | Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | KPS |