CLASS II Device recall · Reported 15 Apr 2020 · FDA Enforcement Report
Zimmer Oscillating Saw Blade -Cutting xintended recalled
Synvasive Technology is recalling Zimmer Oscillating Saw Blade -Cutting xintended for bone or cartilage in orthopedic, distributed in Alabama, New York. The recall was initiated on 27 Jul 2018 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-1676-2020
- FDA event ID
- 85223
- Recalling firm
- Synvasive Technology, El Dorado Hills, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jul 2018
- FDA classified
- 6 Apr 2020
- Reported
- 15 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 27 Jul 2018 | Recall initiated by company | |
| 6 Apr 2020 | Classified by FDA | +619 days |
| 15 Apr 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
Product as listed by the FDA
ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer
Where it was distributed
US distribution to states of AL and NY
Questions about this recall
Why was it recalled?
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
Which lots are affected?
Lot Number/UDI: 265474 (01)00846795028320(17)220414(10)265474 304117 (01)00846795028320(17)230131(10)304117 317918 (01)00846795028320(17)230531(10)317918
Where was it sold?
US distribution to states of AL and NY
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.
More recalls from Synvasive Technology
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Zimmer Oscillating Flat - TS ST Hub recalled by Synvasive Technology | Synvasive Technology | Foreign Material | CA, CT, MA |
| Device | CLASS II | Product products recalled by Synvasive Technology | Synvasive Technology | Labeling Errors | Nationwide |
| Device | CLASS II | The Oxford Partial Knee recalled by Synvasive Technology | Synvasive Technology | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,118| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Halyard Anterior Hip Pack recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard Anterior Hip Pack recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Hip Scope Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | TS Femoral Prep Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | Grafton" DBM and Grafton Plus" DBM contain demineralized recalled | Medtronic Sofamor Danek USA | Other Bacterial Contamination | Nationwide |