Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminu
FDA device recall Z-1089-2015 · posted 2015-02-11 · Terminated
Recall details
- Recalling firm
- Biomet Spine, LLC
- Reason for recall
- The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient.
- Action taken
- Consignees were informally contacted 12/16/2011 of units in the field requesting retrieval. All units were in Lanx's (Biomet's) possession at the time of the recall initiation on 12/19/2011.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 10
- Distribution
- Distributed to TX, OH, NE and NY.
- Date initiated
- 2011-12-19
- Date posted
- 2015-02-11
- Date terminated
- 2015-03-23
- Location
- Broomfield, CO
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