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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Hgp ii acetabular cup bone Screw

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 Class 2 Device Recall Zimmer Hgp ii acetabular cup bone Screwsee related information
Date Initiated by FirmMay 04, 2016
Date PostedMay 16, 2016
Recall Status1 Terminated 3 on July 05, 2017
Recall NumberZ-1683-2016
Recall Event ID 73981
510(K)NumberK840643 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
ProductHgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560
Code Information LOTS: 63276979 63276976 63245682 63276975 63276977 63301523 63276980 63303436    
Recalling Firm/
Manufacturer		 Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
Manufacturer Reason
for Recall		A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
FDA Determined
Cause 2		Packaging change control
ActionAll distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Quantity in Commerce1199
DistributionWorldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
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 = JDI
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