( Stemcup Medical )

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Medical producrs .n mor1on
Sterncup Medical Products AG
Aargauerst rasse 180
CH-8048 Zürich
Tel.:
Fax.:
E-Mail:
Customer Name
+4 1 (0} 43 311 85 00
+41 (0} 43 311 85 09
[email protected]
www.stemcup.ch
Name Contact Person
Street
State/ City
Zürich, 28 May 2014
Urgent Field Safety Notice
Product Recall
concerning
Cover 15+25 mm for acetabular cup
Sterncup reference.:
CzV 103
Dispatcher:
Sterncup Medical Prod ucts AG
Aarga uerstrasse 180
CH- 8048 Zürich
Recipient:
Leadership Orthopedics, Ort hopaedic Surgeons
ldentification of the affected medical devices:
Product Name
Ref. No.
Batch No.
Cover 15mm for acetabular cup
30.15
1207.4469
The nonconforming cover 15mm was packaged taget her with the following acetabular cups :
Product Name
Ref. No.
Batch No.
ISC-Cup 50/39
320.39.50
1305.4945.315
Xentrax-Cup 46/39
340.39.46
1302 .4808 .315
1307.5012.315
Xentrax-Cup 50/44
340.44.50
1306.4981 .315
Xentrax-Cup 52/44
340.44.52
1302.48 11.315
Product Name
Ref. No.
Batch No.
Cover 25mm for acetabular cup
30.25
1207.4471
The nonconforming cover 25mm was packaged tagether with the following acetabular cups:
Product Name
Ref. No.
Batch No.
SSC-Cup 56/48
361.48.56
1210.4662.315
1302.4848.315
CSC Threaded cup 56/48
52.34.0699
1210.4607.315
CSC Threaded cup 60/52
52 .34 .0700
1210.4608.315
CSC Threaded cup 64/52
52.34.0701
1210.4609.3 15
CSC Threaded cup 68/52
52 .34.0702
12 10.4610.3 15
CSC Threaded cup 72/52
52.34.0703
1210.4611.315
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Med1cal products m mo/Jon
Dear Ladies and Gentlemen,
we, Sterncup Medica l Products AG , would like to inform about a product recall. The affected products
(acetabular cover) were found tobe partially nonconforming, and were packaged tagether w it h CSC-, ISC,SSC- and Xentrax- acetabular cups.
Description of the problern including the determined cause:
lt has been found that the outer diameter of the above listed covers is potentially underdimensioned, w hich
was caused due to manufacturing and inspection failures.
Due to the undersize, the cover can not be placed as designated in the cup.
As the affected covers are packaged tagether w ith the acetabular cups, the above listed cups are being
recalled.
Risk assessment:
The cover could be replaced w ithout anticipated disadvantages or even completely omitted (the intended
use of the acetabular cups also provides the application w ithout the cover). ln case of replacement, the
operation time may be insignificantly langer, if an alternatively availa ble packaged sterile cover is opened and
used.
Actions to be taken by the user:
Piease return the acetabular cups w ith the above listed batch numbers to:
Stemcup Medical Products AG
Ouality Management department
Aargauerstrasse 180
CH- 8048 Zürich
Dissemination of the information described here:
Piease make sure that all employees of your organization who should be informed, as weil as the users of
the aforementioned products, receive knowledge of this Field Safety Notice.
lf you have delivered the products to third parties, please torward a copy of this informat ion to the
appropriate places.
Piease keep this information at least until the action has been completed.
This field action has been reported to the relevant competent authorit ies Swissmedic and BfArM.
We apologize for any inconvenience this action may cause, and thank you fo r you r cooperation.
ln case you have any further questions, please do not hesitate to contact our sales representatives.
Sincerely
Stemcup Medical Products AG
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Thomas Kuoni
CEO/Bol
Tel.: +41(0) 4331 1 8503
Fax: +41 (0) 43 311 85 09
E-Mail: [email protected]
Anja Götz
Head of Ouality/ Regulatory Affairs
Tel.: +41 (0) 43 3 11 85 02
Fax: +41(0) 43 31 1 85 09
E-Mail: [email protected]
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