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PRODUCT
a) NFix II System 150 mm, Catalog number NX60150-1 spinal fusion surgery. Recall # Z-0963-2009;
b) NFix II System 200 mm, Catalog number NX60200-1. Spinal fusion surgery. Recall # Z-0964-2009;
c) N-Hance System 150 mm, Catalog number NH60150-1. Spinal fusion surgery, Recall # Z-0965-2009;
d) TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S Spinal fusion surgery. Recall # Z-0966-2009;
e) NFlex Stabilization System 200 mm, Catalog number NF60020-1. Spinal fusion surgery. Recall # Z-0967-2009;
f) NFlex Stabilization System 150 mm, Catalog number NF60150-1. Spinal fusion surgery. Recall # Z-0968-2009
CODE
a) Lot numbers: P06J01 exp 9/30/07; P06J02 exp 9/30/07; P06M01 exp 12/31/07; P06M02 exp 12/31/07; P07D02 exp 4/30/08; P07H01 exp 8/31/08; and P07J01 exp 9/30/08;
b) Lot number: P07G01 exp 7/31/08;
c) Lot number: P07M01 exp 12/31/08;
d) Lot number: 5764185 exp 5/20/2013;
e) Lot number: NF60003 exp 3/31/07;
f) Lot numbers: P07M01 exp 12/31/08; P07M03 exp 12/31/08; P06H01 exp 8/31/07; P06M01 exp 12/31/07; and P06J01 exp 9/30/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Synthes Spine, West Chester , PA , by e-mail on November 18, 2008 and by letters dated November 19, 2008.
Manufacturer: Synthes ( USA ), Monument, CO. Firm initiated recall is ongoing.
REASON
The dimensional specifications are incorrect.
VOLUME OF PRODUCT IN COMMERCE
1,508 units
DISTRIBUTION
Nationwide and countries of Germany , Denmark , Switzerland and Korea |
