Stryker Mantis Rod Inserter Inner Shaft; Non Sterile; Manufactured by Stryker Spine SAS, Cestas France. Distributed by S
FDA device recall Z-1612-2009 · posted 2009-07-07 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the split sphere may separate and fall into the patient.
- Action taken
- Stryker Spine issued an "Urgent Product Recall" notification dated April 29, 2009 via Federal Express to all Consignees. Users were instructed to quarantine all affected product and fax a copy of the Product Accountability Form to 201-760-8406. A Stryker sales representative will retrieve the quarantined product. For further information, contact Stryker Spine at 201-760-8206.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MNH
- Quantity affected
- 387 in US
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-04-30
- Date posted
- 2009-07-07
- Date terminated
- 2013-01-23
- Location
- Allendale, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MANTIS SPINAL SYSTEM (K061813) | Stryker Spine | 2006-09-19 |