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U.S. Department of Health and Human Services

Class 3 Device Recall SLIM Handle

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  Class 3 Device Recall SLIM Handle see related information
Date Initiated by Firm April 03, 2020
Create Date May 15, 2020
Recall Status1 Terminated 3 on November 20, 2020
Recall Number Z-2038-2020
Recall Event ID 85531
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
Code Information SLIM Handle with Catalog #SLM-HND100 with etched lot code #B204-1 on the handle and with Lot# B204-01 on the packaging label.
Recalling Firm/
Manufacturer		 Pega Medical Inc.
1111 Chomedey (A-13) E
Laval Canada
For Additional Information Contact Enrique Garcia
450-688-5144
Manufacturer Reason
for Recall		 The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 04/03/2020 Pega Medical Inc. sent out an email which included a Field Safety Notice letter to their US consignee identifying the problem, the actions to be taken by the customer/user in order to prevent risks for patients/users, and the actions planned by Pega Medical Inc. to correct the problem. PRODUCTS: The Handle of the Driver of the Simple Locking intramedullary System (SLIM) WITH CATALOG # SLM-HND100 which was distributed to the identified US consignee on 12/24/2019, with lot #8204-1 marked on the part (the driver handle) and with packaging labeled with lot# 8204-01. ACTION TO BE TAKEN BY THE CUSTOMER/USER: "Identify the device with the same catalogue number and lot number "Verify and correct any record on your files that may indicate the lot number of this part. The lot indicated in the records must be 8204-1. "If the part is still in its original package: Place provided label over the previous label making sure that all the information in the previous label is completely hidden. "If the part is not in its original package: No further action is required.
Quantity in Commerce 3 units
Distribution US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.
Total Product Life Cycle TPLC Device Report
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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