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U.S. Department of Health and Human Services

Class 2 Device Recall Howmedica Osteonics Corp.

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  Class 2 Device Recall Howmedica Osteonics Corp. see related information
Date Initiated by Firm February 03, 2014
Date Posted April 02, 2014
Recall Status1 Terminated 3 on December 02, 2014
Recall Number Z-1317-2014
Recall Event ID 67734
510(K)Number K993768  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
Product Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants.
Code Information v40 Hip Stem -Right Size # 3: catalog # 6265-5113 lot code #43317101, v40 Hip Stem -Left Size # 4: catalog #6265-5104 lot code #43316801, lot code 43316901, v40 Hip Stem - Right Size #4: catalog #6265-5114 lot code #43113901
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Ms. Christie Samsa
201-831-6365
Manufacturer Reason
for Recall		 Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right Size #3.
FDA Determined
Cause 2		 Error in labeling
Action Stryker sent an Urgent Medical Device Recall Notification letters and Product Accountability Forms to Hospital Risk Management, Chief of Orthopaedics, and Surgeons via Fed Ex with return receipt on February 26, 2014. The letter identified the affected product, problem and actions to be taken. Customer were instructed to return the affected product to the attention of Regulatory Compliance. Please attach the fluorescent orange PRODUCT REMEDIATION sticker to your return. For questions call 201-972-2100.
Quantity in Commerce 48 units
Distribution USA Nationwide Distribution
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.
510(K) Database 510(K)s with Product Code = MEH and Original Applicant = HOWMEDICA OSTEONICS CORP.
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