Recall Z-0997-2024
Globus Medical, Inc. · initiated December 11, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
Codes / lots: Lot Number UDI: GBY094NA (01)00193982302320(17)280311(10)GBY094NA; GBY094MA (01)00193982302320(17)280311(10)GBY094MA; GBY094JA (01)00193982302320(17)280311(10)GBY094JA; GBY094HA (01)00193982302320(17)280311(10)GBY094HA; GBY093XA (01)00193982302320(17)280311(10)GBY093XA; GBY093VA (01)00193982302320(17)280311(10)GBY093VA; GBY094NA-RB (01)00193982302320(17)280311(10)GBY094NA-RB; GBY094MA-RB (01)00193982302320(17)280311(10)GBY094MA-RB; GBY094JA-RB (01)00193982302320(17)280311(10)GBY094JA-RB; GBY094HA-RB (01)00193982302320(17)280311(10)GBY094HA-RB; GBY093XA-RB (01)00193982302320(17)280311(10)GBY093XA-RB; GBY093VA-RB (01)00193982302320(17)280311(10)GBY093VA-RB
Reason for recall
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
FDA-determined cause: Package design/selection
Action taken
Globus Medical issued Urgent Medical Device Recall Notification letter on 12/11/23. Letter states reason for recall, health risk and action to take: Customers are instructed to immediately return all affected sterile-packed Cranial Drills to Globus Medical and complete the attached Response Card. Report any adverse events believed to be associated with the affected sterile-packed Cranial Drills to Globus Medical immediately. For Questions and Support: Globus Medical Contact Contact Information Areas of Support Globus Medical Complaint Handling Unit Fax: 610-300-1342 Email: recall@globusmedical.com Recall Related Questions
Details
- Recall number
- Z-0997-2024
- Initiated
- December 11, 2023
- Posted by FDA
- February 6, 2024
- Product code
- HAW – Neurological Stereotaxic Instrument
- Distribution
- Worldwide - US Nationwide and the countries of Czech Republic, Poland.
- Recalling firm
- Globus Medical, Inc., Audubon, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0995-2024 Class II | Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation…Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have… | 12/11/2023Open, Classified |
| Z-0996-2024 Class II | Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation…Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have… | 12/11/2023Open, Classified |