Z-0641-2010

Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Implant Insertion...

Name: Z-0641-2010 Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Implant Insertion...
Creator: Orthofix, Inc
Published: 2009-11-19
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2009-11-19 / Terminated / root cause: manufacturing process

FDA source

Orthofix, Inc began a recall of Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide... on 2009-11-19. The reason FDA records is "The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0641-2010
Status: Terminated
Initiated: 2009-11-19
Posted: 2010-01-15
Terminated: 2010-02-02
Recalling firm: Orthofix SRL
Product: 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.
Product code: MQP Spinal Vertebral Body Replacement Device
Reason for recall: The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A notification letter dated November 19, 2009 was sent to customers via Federal Express. The letter described the recalled product (PILLAR SA Implant Insertion Instrument, 49-1100) and problem and actions for customers to take. The affected product, PILLAR SA lmplant lnsertion lnstrument, 49-1100 is in the PILLAR SA set (set part number 49-0021) which was shipped to customers. An enclosed attachment provide instructions on product removal and return. Customers were instructed to complete the enclosed Tracking and Verification Form and fax to Orthofix Spinal Implants at 1-973-406-2912. A replacement instrument will be provided as available. In the interim, the Implant Inserter (Part Number 49-1000) included in the PILLAR SA UPE set (set number 49-0020) that was provided earlier this year may be used as an alternative to the affected product. For questions regarding the removal and return of the recalled product to Orthofix Spinal Implants, please contact your Account Services Representative. Direct other questions to the Regulatory Affairs Department at 1-973-406-2812. Direct product questions to Marketing at 1-862-221-1335 or Product Development at 1-973-406-2824.
Quantity in commerce: 29 instruments
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 codes and lots: Part number: 49-1100, Lot Number 17301-L125.

Product code MQP

K081849Class IIBlackstone Pillar Sa Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. / cleared 2008-08-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)