CLASS II Device recall · Reported 27 May 2020 · FDA Enforcement Report
Stryker Orthopaedics-Restoration Anatomic Hemispherical recalled
Howmedica Osteonics is recalling Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, distributed in 30 states. The recall was initiated on 16 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2099-2020
- FDA event ID
- 85583
- Recalling firm
- Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Apr 2020
- FDA classified
- 21 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 16 Apr 2020 | Recall initiated by company | |
| 21 May 2020 | Classified by FDA | +35 days |
| 27 May 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, Catalog # 504-02-68F-R, UDI (01)07613327012514(17)
Where it was distributed
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
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaIowaIllinoisKansasLouisianaMassachusettsMarylandMichiganMissouriMississippiNorth CarolinaNew HampshireNew Jersey
Questions about this recall
Is Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile recalled?
Yes. Howmedica Osteonics recalled Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile on 16 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2099-2020.
Why was it recalled?
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.
Which lots are affected?
Lot #s DD6E5N, 3314LE, EA67YJ, TA05PD, MJ71XA, VH242D, HR43JY, 5E8XPW, KR4YH2, XW7T57, W92MH8, DY1N6E, 4D8EEY, 6M7D2N, 1T81T1, V45AA1, YL2DP4, H017J0, 850EJX, DA1ATY, E78XK4, KN8JXW, VH5DWP, JX71XR, 148L96, KR69DY, M109P1, MK3VNM, X50AR7, KW011V, XM59HJ, 8Y47TR, JD72RX, ND5JDA, T92XV4, 5K7V66, YN3J9D, 8J4YER, A74527, KE1HDR, H5565X, 4L4K4N, PT47V2, 6J83LP, RX1MM4, 5L6P60, L90X5H, 7X117R, MA78Y5
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |