Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bu
FDA device recall Z-1435-2010 · posted 2010-04-28 · Terminated
Recall details
- Recalling firm
- Orthofix Srl
- Reason for recall
- During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.
- Action taken
- Orthofix issued an "Urgent: Field Safety Notice" dated February 22, 2010. Consignees were informed of the affected product and instructed to cease use and to return the product to the firm.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JDW
- Quantity affected
- 25
- Distribution
- Nationwide Distribution -- TX, ND, NY, FL and CA.
- Date initiated
- 2010-02-22
- Date posted
- 2010-04-28
- Date terminated
- 2010-05-05
- Location
- Bussolengo Verona, Italy
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHOFIX MODULSYSTEM (K955848) | Orthofix, Inc. | 1996-03-20 |