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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics

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  Class 2 Device Recall Stryker Orthopaedics see related information
Date Initiated by Firm April 16, 2020
Date Posted May 07, 2020
Recall Status1 Open3, Classified
Recall Number Z-2084-2020
Recall Event ID 85583
510(K)Number K151264  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
Code Information Lot #s JD8WN9, 6514K5, AD78D5, TR0M4X, YT7R3V, 2A7V17, Y81WDV, AN2DME, 514WVN, 9P3WE4, LD3LAL, L21A8P, K02EYK, 6K0J1W, XK44M4, H55J1M, T10T38, VT07WW, 7T1WTE, 6544JE, J45R2R, 8963DT, LV2EW7, PN1X3T, DN0276, RP35M3, T245XV, 497H8P, LJ52DA, HP48J3, H98XN3, 9E8M7P, 1J1RDH, R235KJ, 793724, RA44MH, JJ65MR, N12K3P, PX3TTK, 425H7M, 3V6JAM, P52HME, WX80AA, K65W39, 1R40DL  
Recalling Firm/
Manufacturer
Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Ms. Elizabeth Beato
201-831-5838
Manufacturer Reason
for Recall
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
FDA Determined
Cause 2
Packaging
Action Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm  68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Quantity in Commerce 4895
Distribution Worldwide distribution including the following states: New York, Arkansas, Oklahoma, Michigan, Delaware, Texas, Louisiana, California, Florida, Arizona, Nevada, Ohio, Colorado, Rhode Island, Iowa, Pennsylvania, Massachusetts, North Carolina, Alabama, New Hampshire, Illinois, New Jersey, Virginia, Utah, Maryland, Mississippi, Missouri, Tennessee, Connecticut, and Kansas
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = STRYKER ORTHOPAEDICS
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