| Class 2 Device Recall Poly Component Trial, CR | |
Date Initiated by Firm | February 20, 2017 |
Create Date | March 21, 2017 |
Recall Status1 |
Terminated 3 on October 27, 2017 |
Recall Number | Z-1515-2017 |
Recall Event ID |
76694 |
510(K)Number | K150496 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | Poly Component Trial, CR, packaged in the following sizes and configurations:
a) Poly Component Trial - CR 3x10, REF 90-SRK-160310
b) Poly Component Trial - CR 3x12, REF 90-SRK-160312
c) Poly Component Trial - CR 3x14, REF 90-SRK-160314
d) Poly Component Trial - CR 4x10, REF 90-SRK-160410
e) Poly Component Trial - CR 4x12, REF 90-SRK-160412
f) Poly Component Trial - CR 4x14, REF 90-SRK-160414
g) Poly Component Trial - CR 5x10,REF 90-SRK-160510
h) Poly Component Trial - CR 5x12, REF 90-SRK-160512
i) Poly Component Trial - CR 5x14, REF 90-SRK-160514
j) Poly Component Trial - CR 6x10, REF 90-SRK-160610
k) Poly Component Trial - CR 6x12, REF 90-SRK-160612
l) Poly Component Trial - CR 6x14, REF 90-SRK-160614
The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint |
Code Information |
Lot Numbers: a) REF 90-SRK-160310, TU53730-01 b) REF 90-SRK-160312, TU53731-01 c) REF 90-SRK-160314, TU53732-01 d) REF 90-SRK-160410, TU53730-02 e) REF 90-SRK-160412, TU53731-02 f) REF 90-SRK-160414, TU53732-02 g) REF 90-SRK-160510, TU53730-03 h) REF 90-SRK-160512, TU53731-03 i) REF 90-SRK-160514, TU53732-03 j) REF 90-SRK-160610, TU53730-04 k) REF 90-SRK-160612, TU53731-04 l) REF 90-SRK-160614, TU53732-04 |
Recalling Firm/ Manufacturer |
Medtronic Sofamor Danek USA Inc 1800 Pyramid Pl Memphis TN 38132-1703
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For Additional Information Contact | Eric Epperson 901-344-1435 |
Manufacturer Reason for Recall | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Medtronic initiated their recall on 20 February 2017, by letter delivered by Fed Ex . The letter was addressed to the Risk/Materials Manager and stated that a Medtronic Clinical Specialist would coordinate the removal of the Responsive Orthopedics Total Knee Arthroplasty (TKA) System instrument sets from the premises. Customers with questions were instructed to contact the Medtronic Post-Market Quality Team at 901-399-3197. |
Distribution | US distribution to AR, MA |
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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510(K) Database | 510(K)s with Product Code = JWH
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