4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage

FDA device recall Z-2157-2016 · 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

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