Z-1066-2014Class II

Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications...

Name: Z-1066-2014 Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications...
Creator: Smith & Nephew Inc
Published: 2014-01-23
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2014-01-23 / Terminated

FDA source

Smith & Nephew Inc began a recall of 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... on 2014-01-23. FDA classified it as Class II and gives the reason as "Inner spherical radius of the shell is undersized". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1066-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-23
Posted: 2014-02-21
Terminated: 2016-11-15
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.
Product code: MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Reason for recall: Inner spherical radius of the shell is undersized.
FDA 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 [email protected] 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 in commerce: 10 units
Distribution: Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.
Product codes and lots: Batch No. 13EM03053

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1066-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1066-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21

Product code MBL

K960094Class IIReflection Dual Dimension ShellSmith & Nephew Richards, Inc. / cleared 1996-03-27

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)