Stryker Reflex Hybrid Screw Extractor; Not Sterile: Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in t
FDA device recall Z-0762-2010 · posted 2010-04-12 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.
- Action taken
- An "Urgent Product Recall" letter was sent to Stryker Branches/Agencies on October 12, 2009 and to surgeons who have used the device on October 26, 2009. The recall letter described the affected products, issue and potential hazards. Consignees were instructed to examine their inventory and hospital locations for the affected products and return to Stryker Spine as indicated in the recall letter. Customers were also instructed to complete the enclosed Customer Response form and fax to 1-201-760-8370. Direct questions about the recall to Stryker Spine by calling 1-201-760-8206.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 1,791
- Distribution
- Worldwide Distribution.
- Date initiated
- 2009-10-12
- Date posted
- 2010-04-12
- Date terminated
- 2012-09-06
- Location
- Allendale, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REFLEX HYBRID ACP SYSTEM (K062310) | Stryker Spine | 2006-08-18 |