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
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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
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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 |
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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 = MEH
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