PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
This recall has been terminated (originally issued January 3, 2014).
- Company
- Spinefrontier, Inc.
- Recall Initiated
- September 11, 2013
- Posted
- January 3, 2014
- Terminated
- October 8, 2014
- Recall Number
- Z-0624-2014
- Quantity
- 13 devices
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
Distribution
US Distribution: including states of: TX and VA.
Lot / Code Info
Lot: 012212-001
Root Cause
Process change control
Action Taken
On 9/13/2013, consignees were notified of the recall via email. They were asked to return the recalled product and complete and return the recall acknowledgement form via email or fax.
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