Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
This recall has been terminated (originally issued July 16, 2014).
- Company
- Innovasis, Inc
- Recall Initiated
- July 7, 2014
- Posted
- July 16, 2014
- Terminated
- August 11, 2014
- Recall Number
- Z-2067-2014
- Quantity
- 32
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Distribution
Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
Lot / Code Info
E2S47525 Lot 1301 and E2S47535 Lot 1301
Root Cause
Process control
Action Taken
Distributors were notified by e-mail on 7/7/14, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis. Distributors have been instructed to return all inventory in stock.
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