NFlex Stabilization System 150 mm, Catalog number NF60150-1. spinal fusion surgery
This recall has been terminated (originally issued February 3, 2009).
- Company
- Synthes Spine
- Recall Initiated
- November 7, 2008
- Posted
- February 3, 2009
- Terminated
- October 5, 2009
- Recall Number
- Z-0968-2009
- Quantity
- 1508 (total)
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
the dimensional specifications are incorrect
Distribution
Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea.
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
Action Taken
The recalling firm issued an e-mail on 11/18/08 to their sales force to inform them of the problem and the need to remove the product.The recalling firm issued Medical Device recall letters dated 11/19/08 to their customers to inform them of the problem and the need to return the product. Contact Synthes at 800-620-7025 ext. 7025 or 610-719-5750 for additional information.