̸ ̸ Stella.Son@stryker.com
ۼ 2015-01-21 14:58 ȸ 733
÷ (Korean)PFA 2014-126_Recall letter draft_rev02.pdf
Stryker Leibinger GmbH & Co. KG MEDPOR(RA2014-126)
URGENT MEDICAL DEVICE RECALL
 
Ƿ ȸ (RA2014-126)
 
MEDPOR Contoured Two-Piece Chin Implant (𵨸: 86001),
 
MEDPOR BARRIER Sheet Implants (𵨸: 9305 and 9312) and
 
MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MTB - Right (𵨸: 81036)
 
: ǻ, , ũ Ŵ, ڿ
 
* Stryker Leibinger κ Ͽ ǥ/ؼ ̰ ִ (÷) Ͻʽÿ. *
 
 
 
 

Date                                January 21, 2015
 
 
Legal Manufacturer      Stryker Leibinger GmbH & Co. KG, Boetzinger Strasse 41, D-79111 Freiburg,
 
 
Product Recalled       MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm
 
MEDPOR BARRIER Sheets Implants – Orbital Floor & Rectangle Designs
 
MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MTB - Right
 
 
Manufacturer Part Numbers
 
Manufacturer Part Name
 
Lot Numbers
 
86001
 
MEDPOR  Surgical Implant Contoured Two Piece Chin
 
A1405048, A1404026
 
9305
 
MEDPOR BARRIER Sheets – Orbital Floor Implant
 
69698, 77004, 81799, A1310051, A1311008, A1311044, A1312011, A1402023, A1404010
 
9312
 
MEDPOR BARRIER Sheets – Rectangle
 
-       A1403008
 
81036
 
MEDPOR TITAN MAX Orbital Floor and Wall (OFW) Medpor-Titanium-Barrier (MTB) Right
 
-       A1402020, A1405060
 
 
 
ϴ ,
 
Stryker Leibinger GmbH & Co. KG CranioMaxilloFacial ǰ Ͽ ڹ ȸ ġ Ͽϴ.   ڹ ȸ ġ õ ˸ ۼ Ǿϴ.
 
 
Product Issue(ǰ ̽)                  
 
Stryker 86001, 9305 9312 ǰ Ͽ öƮ ļ Ȯ ˰ Ǿϴ. , ̳ porous sheetκ barrier sheet и ȮϿϴ.
 
 
 
Figure 1: Contoured Two-Piece Chin Implant (Part 86001)
 
 
 
Figure 2: BARRIER Sheet Implants (Parts 9305, 9312)
 
 
Stryker 81036 ǰ Part No. ǥð öƮ ǥ鿡 Ȯϰ ġ ʾ öƮ , -Ʒ ȯڿ ߸ Ǵ ʰ ߻ ȮϿϴ.
 
 
 
 
Figure 3: MEDPOR TITAN MAX OFW MTB Right (Part 81036)
 
 
Potential Hazards( ؿ)   
 
ݱ ̷ ̽ λڴ ϴ. Contoured Two-Piece Chin Implant Ǵ BARRIER Sheet implants ջ Ǿٸ, װ ̳ ߿ ߻ ϰų ܰǿ ߰ Դϴ. ļյ , ǻ ü öƮ ؾ մϴ.
 
 
TITAN MAX
Orbital Floor Wall MTB - öƮ barrier öƮ ߸ ġ ù ° ǻ ˻翡 ˴ϴ. ߸ ġ ߰ Ǿ Ŀ ġ ǻ ٸ Ǵ ٸ öƮ Ѵ.

Contoured Two Piece Chin Implant BARRIER Sheet Implants "ջ öƮ" ߻ ִ ֽϴ. õ ɰ 15-60 ̷ ش ջ öƮ  ü(: ) Ǵ ü ߻ մϴ. Stryker öƮ ļ BARRIER սǸ Ǵ ϴ ߻ϴ Ȯϸ Ͽ ִ ǰ ̿Ͽ ذ ȮϿ.  

TITAN MAX
Orbital Floor Wall MTB ޴ öƮ δ "öƮ " ߻ ֽϴ. õ ɰ 15-60 ̿
 
öƮ ü Ǵ ۾ ʿ伺 ( ߰ ð) ̴. Ͽ ִ ǰ ̿Ͽ ذ ȮϿ.  

 
Risk Mitigation( ȭ)
 
1.   IFU ħ ( Ŵ), öƮ ϰų ٷ , ʽÿ. ̴ öƮ ļ ų ֽϴ.
 
2.   ǰ غϰ, Ͻʽÿ.
 
 
Actions Needed(ġ )
 
1.   Ƿ ȸ Ͽ ڿ ˸, ش ڵ鿡 Ͻʽÿ.
 
2.   ǰ Ʒ ּҷ ݼ ֽʽÿ.
 
 
          ѱƮĿ
 
         87 21, 11
 
 
3.   ÷ε ۼ Ͻ ѱƮĿ RA&QA ۺ ֽʽÿ.
 
4.   ۼ Ȯμ(Customer response on receipt form)纻 Ͽ Ͻʽÿ.
 
 
 
ǰ ǰ ۿ ʰ ִٸ Stryker ˷ֽʽÿ.
 
 
ġ Ͽ ˼մϴ.
 
 
ǰ ŷڼ 븦 ϴ ǰ ϸ, ߰ ø ֽñ ٶϴ.
 
 

Modular Capture Distal Resection(RA2014-169)
Stryker Endoscopy Laparoscopic Instruments and Accessories(RA2014-102)
        
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40 Break-Away Femoral Nozzle 2018-02-14 212
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38 Guider Guide Catheter (92193002-FA) 2017-12-14 348
37 MCK Tibial Baseplate 2017-12-12 254
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31 Scorpio Patella Assembly Instrument (RA2016-098) 2016-09-05 577
30 MAKO THA Software Upgrade (RA2016-095) 2016-09-05 455
29 Triathlon Modular Handle (RA2016-077) 2016-07-19 494
28 Target Nano Coil(RA2016-088) 2016-06-20 751
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23 LFIT V40 Vitallium Femoral Heads(RA2014-170EXT) 2015-10-07 1015
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21 MAKO Robotic Arm Interactive Ortho System_RA2014_095 2015-03-24 1146
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