ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument u
FDA device recall Z-0045-2017 · posted 2016-10-05 · Terminated
Recall details
- Recalling firm
- LDR Spine USA, Inc.
- Reason for recall
- The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury
- Action taken
- The firm, LDR, contacted affected consignees via phone and then sent a follow up email dated 9/8/16. The phone script and email described the product, problem and actions to be taken. The consignees were instructed to promptly return the instrument using the RMA#1180. The firm will perform a rework that prevents the binding to occur. If you have any question, contact the Quality Engineering Manager by email: ron.musselman@zimmerbiomet.com, phone: 512-344-3436 or Field Inventory Manager - US Supply Chain or phone: 512-344-3436.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 24 units
- Distribution
- US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
- Date initiated
- 2016-08-29
- Date posted
- 2016-10-05
- Date terminated
- 2017-01-13
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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|---|---|---|
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| MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM (K090507) | Ldr Spine USA | 2009-06-25 |
| LDR SPINE ROI INTERBODY FUSION SYSTEM (K082262) | Ldr Spine USA | 2009-02-02 |