Z-2827-2020Class II

POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 -

Name: Z-2827-2020 POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 -
Creator: Smith & Nephew Orthopaedics AG
Published: 2020-07-22
License: https://open.fda.gov/license/

Smith & Nephew Orthopaedics AG / initiated 2020-07-22 / Open, Classified / root cause: design

FDA source

Smith & Nephew Orthopaedics AG began a recall of POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the... on 2020-07-22. FDA classified it as Class II and gives the reason as "Multiple lots being recalled due to a product design issue". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2827-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-07-22
Posted: 2020-08-19
Recalling firm: Smith & Nephew Orthopaedics AG
Product: POLARSTEM 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.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Multiple lots being recalled due to a product design issue
Root cause tag: design
FDA root cause: Device Design
Action: On 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 [email protected]. 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 [email protected].
Quantity in commerce: 528 unit
Distribution: Worldwide 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.
Product codes and lots: Serial Numbers: A56281, A57539, A58660, A600630, A61590, A62616 & A62689

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2827-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2827-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-19

Product code LZO

K143739Class IIPOLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASmith & Nephew, Inc. / cleared 2015-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)