NFlex Stabilization System 200 mm, Catalog number NF60020-1. spinal fusion surgery
FDA device recall Z-0967-2009 · posted 2009-02-03 · Terminated
Recall details
- Recalling firm
- Synthes Spine
- Reason for recall
- the dimensional specifications are incorrect
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NPQ
- Quantity affected
- 1508 (total)
- 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 K
- Date initiated
- 2008-11-07
- Date posted
- 2009-02-03
- Date terminated
- 2009-10-05
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NGARDE SYSTEM (K072685) | N Spine, Inc. | 2007-10-19 |