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U.S. Department of Health and Human Services

Class 2 Device Recall R3 Forte Ceramic Liners

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  Class 2 Device Recall R3 Forte Ceramic Liners see related information
Date Initiated by Firm March 11, 2011
Date Posted April 22, 2011
Recall Status1 Terminated 3 on February 08, 2012
Recall Number Z-2058-2011
Recall Event ID 58324
PMA Number P030022 
Product Classification liner - Product Code MRA
Product R3 TM CERAMIC ACETABULAR LINER, BIOLOX¿ FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
Code Information 09JT35383
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact David Archer, Group Director
901-396-2121 Ext. 5373
Manufacturer Reason
for Recall		 During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. This has the potential to result in lower than expected strength for the liners.
FDA Determined
Cause 2		 Employee error
Action All affected Smith & Nephew Distributors were notified via email and the hospitals were notified by letter delivered by Fed-Ex on 3/11/2011. They were instructed to immediately cease distribution, quarantine affected product for return, if product further distributed, identify customers and immediately notify them of recall. Please contact Mr. David Archer, Group Director, at 701.396.2121, ext. 5373, if you have questions.
Quantity in Commerce 67 units
Distribution AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, WA, and WI
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.
PMA Database PMAs with Product Code = MRA and Original Applicant = Smith & Nephew, Inc.
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