Enforcement Report - Week of March 20, 2013
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Product Detail
| Product Description | Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation. |
|---|---|
| Recall Number | Z-0932-2013 |
| Classification | Class II |
| Code Info | Part Number: 0609-2809-06, Lot: 39AQ |
| Product Distributed Qty | 3 units |
| Reason For Recall | Implants were incorrectly laser marked as 23mm instead of 28mm. |
Event Detail
| Event Id | 62993 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Spine Smith Partners LP |
| City | Austin |
| State | TX | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-24 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Distributed in Texas. |
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