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

FDA device recall Z-0641-2010 · posted 2010-01-15 · Terminated

Recall details

Recalling firm

Orthofix, Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MQP

Quantity affected

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).

Date initiated

2009-11-19

Date posted

2010-01-15

Date terminated

2010-02-02

Location

McKinney, TX

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