| Class 2 Device Recall 3.5mm Bowed Locking Compression Femur Plates | |
Date Initiated by Firm | July 27, 2016 |
Date Posted | September 19, 2016 |
Recall Status1 |
Terminated 3 on March 24, 2017 |
Recall Number | Z-2844-2016 |
Recall Event ID |
74928 |
510(K)Number | K083286 |
Product Classification |
Screw, fixation, bone - Product Code HWC
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Product | 3.5mm Bowed Locking Compression Femur Plates, 18 hole
Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction. |
Code Information |
Product Number: 00-1050-3218 Lot Number: NM02346 |
Recalling Firm/ Manufacturer |
OrthoPediatrics Corp 2850 Frontier Dr Warsaw IN 46582-7001
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For Additional Information Contact | Greg Teghtmeyer 574-268-6379 |
Manufacturer 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. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | 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). |
Quantity in Commerce | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HWC
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