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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 Orthopaedicssee related information
Date Initiated by FirmApril 16, 2020
Date PostedMay 07, 2020
Recall Status1 Terminated 3 on November 15, 2021
Recall NumberZ-2093-2020
Recall Event ID 85583
510(K)NumberK151264 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
Code Information Lot #s PH230T, 5316PX, 6487DY, MV4KAW, MY6XW7, NY7JW8, XT3NK1, 8J1031, W43YMN, Y363WD, R58ALD, YM0ATP, MD6J43, M04YA2, 1V4RY5, NY85E3, 9439YT, KR3025, NN41PD, W28H8N, 7T0V3R, MT7MA3, PW531T, JT1H7A, WL30XL, LN8LTY, HJ82TV, XN0HR9, RY7TH7, L97718, KN4A66, JE84VV, 5X3H7R, 404547, 86593Y, 7610XX, WY3E23, JH7RH6, HD1H4E, 59725R, T17YD9, KX6P0W, 4A4TW6, 42775A, E02TD6, 3M44J8, DM2L4J, YX2RMM, 9L6EN0, NJ69D3, 4P7MTN, 2P31RY, 935J0K 
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactMs. 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
ActionStryker 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 Commerce4895
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = LPH
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