| Class 2 Device Recall Stryker Orthopaedics | |
Date Initiated by Firm | April 16, 2020 |
Date Posted | May 07, 2020 |
Recall Status1 |
Terminated 3 on November 15, 2021 |
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
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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
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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 |
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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 = LPH
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