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U.S. Department of Health and Human Services

Class 2 Device Recall PCA 10 Degree Hooded Acetabular Insert ID 22mm

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  Class 2 Device Recall PCA 10 Degree Hooded Acetabular Insert ID 22mm see related information
Date Initiated by Firm October 15, 2015
Date Posted November 17, 2015
Recall Status1 Terminated 3 on June 08, 2017
Recall Number Z-0281-2016
Recall Event ID 72506
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm,
Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
Code Information Catalog Number:Lot Number; 6299-8-403:23182601; 6299-8-469:19123701; 6299-8-525:29115601; 6299-8-525:22727301; 6299-8-581:17772401; 6299-8-581:28432001.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Mr. Eric Petschler
201-831-5000
Manufacturer Reason
for Recall		 Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612.
FDA Determined
Cause 2		 Under Investigation by firm
Action Stryker sent an Urgent Medical Device Recall Notification letter dated October 15, 2015, to all affected customers. The notification instructed consignees on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Customers were instructed to quarantine the affected product. Consignees were asked to complete and return the attached Product Recall Acknowledgement Form within 5 days and either email (strykerortho7984@stericycle.com or Fax (1-866-672-0627 ) the response form back. Customers with questions were instructed to call 201.831.5272.
Quantity in Commerce 1 unit
Distribution Distribution to Virginia only.
Total Product Life Cycle TPLC 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.
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