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 54 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-2085-2020
- 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
- Packaging Defects
- 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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(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
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 6A7N7Y, J50WR6, EM4ED2, 4908KM, K14HL3, VN5NTY, 4X7XE4, JK4A37, W20A86, EM5Y28, H81JNL, EE883L, 9L8LMD, 7Y2HM0, MM0JYY, K23J10, DY42DE, 3P3P64, H77Y5E, MX801E, 1L0758, HM5WKX, D058L6, 4L2R4R, VY0PK4, 872EHV, YD53A4, 4T54D0, 4768E2 WJ0W8W, YV5804, P98YT4, 8N512J, A162RN, J35YL4, H089KL, WW76RP, P58D3J, XH7HN8, RV6DJ8, 8Y0XVE, JM34X2, WJ776A, RH1MRT, N28J76, NP2XXL, L7453E, AA1DYJ, 258Y6J, 6N4X1M, E66DMR, V63W1E, 2739DR, YH1P91, 216NDE, A4410X
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
15 other products · FDA event 85583More recalls from Howmedica Osteonics
All 232| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tri Ts Baseplate Size recalled by Howmedica Osteonics | Howmedica Osteonics | Packaging Defects | Nationwide |
| Device | CLASS II | Tri Ts Baseplate Size recalled by Howmedica Osteonics | Howmedica Osteonics | Packaging Defects | Nationwide |
| Device | CLASS II | MICS3 Angled Sagittal Saw Attachment recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | The Stryker CranialMask Tracker is a single-use device recalled | Howmedica Osteonics | Device Malfunction | Nationwide |
| Device | CLASS II | Exeter V40 Stem No recalled by Howmedica Osteonics | Howmedica Osteonics | Packaging Defects | NJ |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |