Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be util
FDA device recall Z-2053-2015 · posted 2015-07-09 · Terminated
Recall details
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Reason for recall
- The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile, distributed by DePuy Spine Inc.
- Action taken
- On 5/29/15, RTI Surgical sent DePuy/Synthes Spine Inc. with an URGENT: Medical Device Voluntary Recall Notification identifying the recalled product, reason for recall, potential risks, and immediate actions required.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- JDQ
- Quantity affected
- 25
- Distribution
- Distributed in MA.
- Date initiated
- 2015-05-29
- Date posted
- 2015-07-09
- Date terminated
- 2016-03-17
- Location
- Marquette, MI
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