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Class 2 Device Recall Xcelerate Specialty Patella Milling System |
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Date Initiated by Firm |
January 27, 2011 |
Date Posted |
March 31, 2011 |
Recall Status1 |
Terminated 3 on October 15, 2012 |
Recall Number |
Z-1862-2011 |
Recall Event ID |
57852 |
Product Classification |
Gauge, depth - Product Code HTJ
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Product |
Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K2399PR10; Stryker Howmedica Osteonics, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430
The Xcelerate patella milling system (as detailed in surgical protocol LSPK35) was designed to prepare a patella to accept all Scorpio or Duracon patellar implants using either a resurfacing or recessed technique. |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah NJ 07430
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For Additional Information Contact |
Colleen O'Meara 201-831-5970
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Manufacturer Reason for Recall |
Stryker Orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus allowing for the reamer to leave as little as 8.9mm (in a nominal condition) patella bone.
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FDA Determined Cause 2 |
Device Design |
Action |
Stryker sent an Urgent Product Recall letter dated January 27, 2011, via FedEX for January 28, 2011, delivery with return receipt. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were insructed to fax back the attached Product Recall Acknowledgement Form within 5 days to 201-831-6069.
Customers were also instructed to contact the hospitals in their territory that have the affected product to arrange return of the product.
Product should be returned to the attention of:
Regulatory Compliance
Stryker Orthopaedics
325 Corporate Drive
Mahwah, New Jersey, 07430.
The orange Product Remediation sticker should be attached to the return, indicating the Product Remediation # RA 2009-296. Mark the outer box with words "Product Recall."
For questions regarding this recall call (201) 972-2100. |
Quantity in Commerce |
52 units |
Distribution |
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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