Date Initiated by Firm | January 22, 2018 |
Create Date | April 02, 2018 |
Recall Status1 |
Terminated 3 on September 24, 2019 |
Recall Number | Z-1291-2018 |
Recall Event ID |
79530 |
510(K)Number | K080753 K102081 |
Product Classification |
Implantable Clip appliers - Product Code FZP
|
Product | DS Titanium Ligation Clip Appliers, used in laparoscopic surgery |
Code Information |
DS Clip Appliers - Product Numbers PL808R DS SINGLE FIRE LAP.APPLIER L 12/310MM PL802R DS SINGLE FIRE LAP.APPLIER SM 5/310MM PL826R DS SINGLE FIRE LAP.APPLIER M 10/420MM PL817R DS SINGLE FIRE LAP.REM.FORC.ML 10/310MM PL828R DS SINGLE FIRE LAP.APPLIER L 12/420MM PL809R DS SINGLE FIRE LAP.APPLIER XL 12/310MM PL806R DS SINGLE FIRE LAP.APPLIER M 10/310MM PL818R DS SINGLE FIRE LAP.REM.FORC.L 12/310MM PL801R DS SINGLE FIRE LAP.APPLIER S 5/310MM PL816R DS SINGLE FIRE LAP.REM.FORC.M 10/310MM PL807R DS SINGLE FIRE LAP.APPLIER ML 10/310MM PL822R DS SINGLE FIRE LAP.APPLIER SM 5/420MM PL827R DS SINGLE FIRE LAP.APPLIER ML 10/420MM |
Recalling Firm/ Manufacturer |
Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217
|
For Additional Information Contact | Val Strawn 610-984-9414 |
Manufacturer Reason for Recall | Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions. |
FDA Determined Cause 2 | Labeling design |
Action | A letter and copy of the updated IFU was sent to affected customers the week of January 15, 2018. Product does not need to be returned.
IFU is revised and put on the Aesculap Website for usage. https://www.aesculapusa.com/products/instructions-for-use. |
Quantity in Commerce | 270 |
Distribution | US and Canada distribution |
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 = FZP
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