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U.S. Department of Health and Human Services

Class 2 Device Recall Poly Component Trial, PS

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 Class 2 Device Recall Poly Component Trial, PSsee related information
Date Initiated by FirmFebruary 20, 2017
Create DateMarch 21, 2017
Recall Status1 Terminated 3 on October 27, 2017
Recall NumberZ-1516-2017
Recall Event ID 76694
510(K)NumberK150496 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductPoly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g) Poly Component Trial - PS 5x10, REF 90-SRK-180510 h) Poly Component Trial - PS 5x12, REF 90-SRK-180512 i) Poly Component Trial - PS 5x14, REF 90-SRK-180514 j) Poly Component Trial - PS 6x10, REF 90-SRK-180610 k) Poly Component Trial - PS 6x12, REF 90-SRK-180612 l) Poly Component Trial - PS 6x14, REF 90-SRK-180614 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-180310, TU53738-01 b) REF 90-SRK-180312, TU53739-01 c) REF 90-SRK-180314, TU53740-01 d) REF 90-SRK-180410, TU53738-02 e) REF 90-SRK-180412, TU53739-02 f) REF 90-SRK-180414, TU53740-02 g) REF 90-SRK-180510, TU53738-03 h) REF 90-SRK-180512, TU53739-03 i) REF 90-SRK-180514, TU53740-03 j) REF 90-SRK-180610, TU53738-04 k) REF 90-SRK-180612, TU53739-04 l) REF 90-SRK-180614, TU53740-04 
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl
Memphis TN 38132-1703
For Additional Information ContactEric 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
ActionMedtronic 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.
Quantity in Commerce111 units
DistributionUS distribution to AR, MA
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = JWH
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