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U.S. Department of Health and Human Services

Class 2 Device Recall POLARSTEM COLLAR Reamer Guide

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 Class 2 Device Recall POLARSTEM COLLAR Reamer Guidesee related information
Date Initiated by FirmJuly 22, 2020
Create DateAugust 19, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2827-2020
Recall Event ID 86099
510(K)NumberK143739 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
ProductPOLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.
Code Information Serial Numbers: A56281, A57539, A58660, A600630, A61590, A62616 & A62689
Recalling Firm/
Manufacturer		 Smith & Nephew Orthopaedics AG
Schachenallee 29
Aarau Switzerland
For Additional Information ContactHeidi Rowland
503-267-6240
Manufacturer Reason
for Recall		Multiple lots being recalled due to a product design issue
FDA Determined
Cause 2		Device Design
ActionOn July 22, 2020, Urgent Medical Device recall notice was send out to customers. The notification states the following action to be taken: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table. 2. If you have no product to return, please put an X in the appropriate location. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to FieldActions@smith-nephew.com. Please Note  even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.
Quantity in Commerce528 unit
DistributionWorldwide distribution - US Nationwide distribution including in the state of TN and the countries of AU, BE, CA, CH, ES, FR, GB, JP, NL, NO, PL, SG, ZA.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LZO
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