Z-2097-2020Class II

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog #...

Name: Z-2097-2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog #...
Creator: Howmedica Osteonics Corp.
Published: 2020-04-16
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2020-04-16 / Terminated / root cause: packaging

FDA source

Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17) on 2020-04-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2097-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-16
Posted: 2020-05-07
Terminated: 2021-11-15
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17)
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
Root cause tag: packaging
FDA root cause: 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
Product codes and lots: Lot #s 1X5DJK, NH4W8Y, 744EH9, AD25RA, 7E4HW3, 1N21NK, E00T60, WY1DD1, D26R36, H74H7L, RT0AK2, 593Y5R, AD00T8, E12H25, 9K66L6, AL7K8E, MP11MY, D04T4A, 8K74RX, 1R57DY, NH0352, KW5K62, 767RKK, V21PPJ, 6580X6, X73EDY, 5A1ANY, LJ0DWY, RR0T4W, JA761W, N11LR0, 1A03DE, 5E7XRM, TW81AP, 7E69MM, M42Y3R, A28827, 5N1DTH, Y6782W, J33J50, D930PJ, XR6WL0, TH4ED5, J54YNJ, D755P9

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2097-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2084-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2085-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2086-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2087-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2088-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2089-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2090-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2091-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2092-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2093-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2094-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2095-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2096-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2097-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2098-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2099-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21

Product code LPH

K151264Class IIRestoration Anatomic ShellStryker Orthopaedics / cleared 2015-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)