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Devices
Device Recall BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
Model / Serial
Part number: 49-1100, Lot Number 17301-L125.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
United States (IA, NV, CO, AZ, NY, MD, IL, VA, MN, MI, NC, CT, LA, AR, GA, CA, MO, WA, OK and AL).
Product Description
Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. || Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill Tips, Cover Plate Inserter, Cover Plate Driver, Cover Plate Holder, Ratcheting Handle, Torque Limiting Handle, Hex Driver, Distractors/Sizers, Sizers REF: 49-0021: Orthoflex Spinal Implants, 1211 Hamburg Tnpk, Suite 300, Wayne, NJ 07470. || The Pillar SA Implant Insertion Instrument is intended for intraoperative use in placing/inserting Pillar SA implants into a prepared interbody space.
Manufacturer
Orthofix, Inc
1 Event
Recall of Device Recall BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
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Manufacturer
Orthofix, Inc
Manufacturer Address
Orthofix, Inc, 1720 Bray Central Dr, McKinney TX 75069-8207
Manufacturer Parent Company (2017)
Orthofix International Nv
Source
USFDA
Language
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