| Class 2 Device Recall R3 Forte Ceramic Liners | |
Date Initiated by Firm | March 11, 2011 |
Date Posted | April 22, 2011 |
Recall Status1 |
Terminated 3 on February 08, 2012 |
Recall Number | Z-2053-2011 |
Recall Event ID |
58324 |
PMA Number | P030022 |
Product Classification |
liner - Product Code MRA
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Product | R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
Usage: Primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis or traumatic arthritis |
Code Information |
09ET31294, 09FT32646M 09FT32802, 09FT32803, and 09FT33252 |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 1450 E. Brooks Rd Memphis TN 38116
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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 | 296 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 |
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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.
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PMA Database | PMAs with Product Code = MRA
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