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FDA device recall Z-2349-2015 · posted 2015-08-06 · Terminated

Recall details

Recalling firm

Zimmer Surgical Inc

Reason for recall

The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.

Action taken

Zimmer sent an Urgent Medical Device Correction letter dated June 30, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification, identify the affected product and replace the IFU with the enclosed corrected IFU. Customers were also instructed to complete the attached Response Form and return it via email to CorporateQuality.PostMarket@zimmer.com. Customers with questions were instructed to call 330-364-0989.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

KCY

Quantity affected

330 units

Distribution

Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA

Date initiated

2015-06-24

Date posted

2015-08-06

Date terminated

2016-11-04

Location

Dover, OH