Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voi
FDA device recall Z-0123-2014 · posted 2013-10-31 · Terminated
Recall details
- Recalling firm
- Globus Medical, Inc.
- Reason for recall
- The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
- Action taken
- Globus sent an Urgent: Medical Device Recall Notification letter, dated August 28, 2013 to customers/users. The letter identified the affected units, issue, potential risk, product, and actions to be taken. Customers were requested to complete the attached response card and return of the affected product to Globus Medical. For questions and support contact Globus Medical by fax 1-610-300-1342 or email:recall@globusmedical.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 193
- Distribution
- USA Nationwide Distribution.
- Date initiated
- 2013-08-28
- Date posted
- 2013-10-31
- Date terminated
- 2014-11-14
- Location
- Audubon, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROFUSE PUTTY AND MICROFUSE ST MIS (K102392) | Globus Medical, Inc. | 2010-12-22 |