Date Initiated by Firm | January 11, 2016 |
Date Posted | March 12, 2016 |
Recall Status1 |
Terminated 3 on April 13, 2017 |
Recall Number | Z-1157-2016 |
Recall Event ID |
72900 |
510(K)Number | K113369 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product | Product 59 consists of all product under product code: JWH and same usage:
Item no:
42540000026 PSN ALL POLY PAT PLY 26MM
42540000029 PSN ALL POLY PAT PLY 29MM
42540000032 PSN ALL POLY PAT PLY 32MM
42540000035 PSN ALL POLY PAT PLY 35MM
42540000038 PSN ALL POLY PAT PLY 38MM
42540000041 PSN ALL POLY PAT PLY 41MM
42511000510 PSN ASF CR 10MM PLY L 3-1
42511000410 PSN ASF CR 10MM PLY L 3-9
42511000610 PSN ASF CR 10MM PLY L 7-1
42521000510 PSN ASF CR 10MM PLY R 3-1
42521000410 PSN ASF CR 10MM PLY R 3-9
42521000610 PSN ASF CR 10MM PLY R 7-1
42511000511 PSN ASF CR 11MM PLY L 3-1
42511000411 PSN ASF CR 11MM PLY L 3-9
42511000611 PSN ASF CR 11MM PLY L 7-1
42521000511 PSN ASF CR 11MM PLY R 3-1
42521000411 PSN ASF CR 11MM PLY R 3-9
42521000611 PSN ASF CR 11MM PLY R 7-1
42511000512 PSN ASF CR 12MM PLY L 3-1
42511000412 PSN ASF CR 12MM PLY L 3-9
42511000612 PSN ASF CR 12MM PLY L 7-1
42521000512 PSN ASF CR 12MM PLY R 3-1
42521000412 PSN ASF CR 12MM PLY R 3-9
42521000612 PSN ASF CR 12MM PLY R 7-1
42511000513 PSN ASF CR 13MM PLY L 3-1
42511000413 PSN ASF CR 13MM PLY L 3-9
42511000613 PSN ASF CR 13MM PLY L 7-1
42521000513 PSN ASF CR 13MM PLY R 3-1
42521000413 PSN ASF CR 13MM PLY R 3-9
42521000613 PSN ASF CR 13MM PLY R 7-1
42511000514 PSN ASF CR 14MM PLY L 3-1
42511000414 PSN ASF CR 14MM PLY L 3-9
42511000614 PSN ASF CR 14MM PLY L 7-1
42521000514 PSN ASF CR 14MM PLY R 3-1
42521000414 PSN ASF CR 14MM PLY R 3-9
42521000614 PSN ASF CR 14MM PLY R 7-1
42511000516 PSN ASF CR 16MM PLY L 3-1
42511000416 PSN ASF CR 16MM PLY L 3-9
42511000616 PSN ASF CR 16MM PLY L 7-1
42521000516 PSN ASF CR 16MM PLY R 3-1
42521000416 PSN ASF CR 16MM PLY R 3-9
42521000616 PSN ASF CR 16MM PLY R 7-1
42511000518 PSN ASF CR 18MM PLY L 3-1
42511000418 PSN ASF CR 18MM PLY L 3-9
42511000618 PSN ASF CR 18MM PLY L 7-1
42521000518 PSN ASF CR 18MM PLY R 3-1
42521000418 PSN ASF CR 18MM PLY R 3-9
42521000618 PSN ASF CR 18MM PLY R 7-1
42511400810 PSN ASF PS 10MM PLY L 10-
42511401010 PSN ASF PS 10MM PLY L 10-
42511400410 PSN ASF PS 10MM PLY L 3-5
42511400610 PSN ASF PS 10MM PLY L 3-5
42511400510 PSN ASF PS 10MM PLY L 6-9
42511400710 PSN ASF PS 10MM PLY L 6-9
42511400910 PSN ASF PS 10MM PLY L 6-9
42521400810 PSN ASF PS 10MM PLY R 10-
42521401010 PSN ASF PS 10MM PLY R 10-
42521400410 PSN ASF PS 10MM PLY R 3-5
42521400610 PSN ASF PS 10MM PLY R 3-5
42521400510 PSN ASF PS 10MM PLY R 6-9
42521400710 PSN ASF PS 10MM PLY R 6-9
42521400910 PSN ASF PS 10MM PLY R 6-9
42511400811 PSN ASF PS 11MM PLY L 10-
42511401011 PSN ASF PS 11MM PLY L 10-
42511400411 PSN ASF PS 11MM PLY L 3-5
42511400611 PSN ASF PS 11MM PLY L 3-5
42511400511 PSN ASF PS 11MM PLY L 6-9
42511400711 PSN ASF PS 11MM PLY L 6-9
42511400911 PSN ASF PS 11MM PLY L 6-9
42521400811 PSN ASF PS 11MM PLY R 10-
42521401011 PSN ASF PS 11MM PLY R 10-
42521400411 PSN ASF PS 11MM PLY R 3-5
42521400611 PSN ASF PS 11MM PLY R 3-5
42521400511 PSN ASF PS 11MM PLY R 6-9
42521400711 PSN ASF PS 11MM PLY R 6-9
42521400911 PSN ASF PS 11MM PLY R 6-9
42511400812 PSN ASF PS 12MM PLY L 10-
42511401012 PSN ASF PS 12MM PLY L 10-
42511400412 PSN ASF PS 12MM PLY L 3-5
42511400612 PSN ASF PS 12MM PLY L 3-5
42511400512 PSN ASF PS 12MM PLY L 6-9
42511400712 PSN ASF PS 12MM PLY L 6-9
42511400912 PSN ASF PS 12MM PLY L 6-9
42521400812 PSN ASF PS 12MM PLY R 10-
42521401012 PSN ASF PS 12MM PLY R 10-
42521400412 PSN ASF PS 12MM PLY R 3-5
42521400612 PSN ASF PS 12MM PLY R 3-5
42521400512 PSN ASF PS 12MM PLY R 6-9
42521400712 PSN ASF PS 12MM PLY R 6-9
42521400912 PSN ASF PS 12MM PLY R 6-9
42511400813 PSN ASF PS 13MM PLY L 10-
42511401013 PSN ASF PS 13MM PLY L 10-
42511400413 PSN ASF PS 13MM PLY L 3-5
42511400613 PSN ASF PS 13MM PLY L 3-5
42511400513 PSN ASF PS 13MM PLY L 6-9
42511400713 PSN ASF PS 13MM PLY L 6-9
42511400913 PSN ASF PS 13MM PLY L 6-9
42521400813 PSN ASF PS 13MM PLY R 10-
42521401013 PSN ASF PS 13MM PLY R 10-
42521400413 PSN ASF PS 13MM PLY R 3-5
42521400613 P |
Code Information |
lot no.: 61987247 62060580 62095143 62234779 62244505 62244506 61987260 62060581 62095146 62113095 62190263 62190265 62268839 62268840 62268841 62284790 62284791 62299465 62299466 62318794 62326957 62328734 62332491 62346392 62363051 62363053 62376636 61987268 62060583 62095147 62113090 62113101 62132939 62132940 62132942 62190289 62190290 62268834 62268835 62268836 62268837 62268838 62284788 62284789 62299453 62299454 62318790 62318791 62326952 62326953 62332486 62332487 62332488 62337857 62337858 62346390 62346391 62352421 62352422 62352423 62363042 62363044 62363045 62371750 62371751 62376627 62376631 62376633 62382635 61987269 62060584 62095150 62113092 62113103 62132943 62143610 62190260 62268830 62268831 62268832 62268833 62284792 62284793 62299457 62299458 62299463 62318792 62326954 62326955 62332489 62332490 62337859 62352425 62363048 62363050 62376624 62376625 62382629 62389123 62394482 62394483 62394484 62401095 61987271 62060585 62095151 62113096 62132944 62190283 62190284 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Recalling Firm/ Manufacturer |
Zimmer Manufacturing B.V. Turpeaux Industrial Park Rd 1 km 123.4 Mercedita PR 00715
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For Additional Information Contact | Consumer Relations Call Center 800-447-5633 |
Manufacturer Reason for Recall | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
FDA Determined Cause 2 | Packaging |
Action | Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to
1.Review the notification and ensure that relevant personnel are aware of the contents.
2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
3. Your Zimmer Biomet sales representative will remove the recalled product from your facility.
4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com.
5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative. |
Quantity in Commerce | 112588 |
Distribution | US Nationwide 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 = JWH
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