4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for f
FDA device recall Z-2156-2016 · posted 2016-07-11 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- Labeling does not match the cleared indications for use in the United States and Canada.
- Action taken
- DePuy Synthes initiated a Field Safety Notice to remove the affected Technique Guides and marketing literature from the field. Sales Consultants and Synthes Trauma Marketing will receive training on affected technique guides and marketing literature which promoted off label use. All technique guides and literature have been put on hold and removed from DePuy Synthes website. Effectiveness of this field action will be tracked using their training system. They will confirm training when completed as a means to measure effectiveness.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 19,497,844 units in total
- Distribution
- US Nationwide Distribution in the states of :AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N/A, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR
- Date initiated
- 2016-02-16
- Date posted
- 2016-07-11
- Date terminated
- 2017-06-01
- Location
- West Chester, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES 6.5 MM CANNULATED SCREW (K021932) | Synthes (Usa) | 2002-09-06 |