Z-0932-2013 Class II Terminated
FDA device recall Z-0932-2013 was initiated by Spine Smith Partners LP on August 24, 2012 and is designated Class II. Reason for recall: Implants were incorrectly laser marked as 23mm instead of 28mm. The recall status is terminated (terminated May 17, 2013). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2013
- Initiation Date
- August 24, 2012
- Termination Date
- May 17, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
Reason for Recall
Implants were incorrectly laser marked as 23mm instead of 28mm.
Distribution Pattern
Distributed in Texas.
Code Information
Part Number: 0609-2809-06, Lot: 39AQ