3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that of

FDA device recall Z-2844-2016 · posted 2016-09-19 · Terminated

Recall details

Recalling firm

OrthoPediatrics Corp

Reason for recall

OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.

Action taken

Orthopediatrics initiated the recall of 3.5mm Bowed Locking Compression Femur Plates by distributing e-mails on 0July 27, 2016, followed by telephone calls to all customers on July 28, 2016. All distributors and direct representatives were sent an e-mail to provide them with a written notification of the voluntary recall and instruct them to quarantine all identified devices from the affected lot numbers immediately. Customers were instructed to quarantine recalled product and response via a hard copy Reply Form that was included in a hard copy of the Recall Notice. Each sales representative was also asked to contact Orthopediatrics Logistics Department to receive a Return Authorization Number for returning recalled product. in order to track their affected plates. If customers have any questions about this recall, they were instructed to reach out to the firm via phone (office: 574-267-0865) or email (acargill@orthopediatrics.com).

Root cause

Labeling mix-ups

Status

Terminated

Product code

HWC

Quantity affected

41

Distribution

Nationwide Distribution to AZ, CA, CO, DE, FL, GA, KY, MI, MN, MO, KY, RI, NY, OH, OR, RI, TN, TX, VA, WA Foreign: None VA/DOD: None

Date initiated

2016-07-27

Date posted

2016-09-19

Date terminated

2017-03-24

Location

Warsaw, IN

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