Smith & Nephew Inc: Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.

Recall number

Z-1066-2014

Recalling firm

Smith & Nephew Inc

Product

Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.

Status

Terminated

Initiated

2014-01-23

Posted

2014-02-21

Terminated

2016-11-15

Reason

Inner spherical radius of the shell is undersized.

Root cause

Under Investigation by firm

Action

Smith & Nephew Inc. sent an Urgent - Product Recall 1st Notification letter dated January 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Actions for Hospital Representatives: 1. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. 2. Complete the last two columns in the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned, and include your phone and fax number in the spaces provided. If you do not have product to return, please place an x in the column No product to return. 3. Please contact Smith & Nephews Safety Affairs Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number. 4. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment. Actions for Smith & Nephew Inventory Specialists 1. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, cease distribution and use of those products, and quarantine them immediately. 2. Carry out a physical count of all affected product in your territory and record this data on the Inventory Return Certification Form on the following page. 3. If you do not have product to return, please place an x in the column No Product to Return, and then fill in the Acknowledgement of Responsibility at the bottom of the form. 4. Fax a copy of the completed Inventory Return Certification Form to: +1-901-566-7975 5. If you have affected products, return the product, along with the completed Inventory Return Certification Form, to the address indicated

Quantity

10 units

Distribution

Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.

Lot, serial or model codes

Batch No. 13EM03053

510(k) numbers

["K960094"]

PMA numbers

not on file

Product code

MBL

Firm FEI

1020279

Firm city

Memphis

Firm state

TN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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