CLASS II Device recall · Reported 30 Dec 2015 · FDA Enforcement Report
Zimmer Oscillating Flat - TS ST Hub recalled by Synvasive Technology
Synvasive Technology is recalling Zimmer Oscillating Flat - TS ST Hub, distributed in California, Connecticut, Massachusetts. The recall was initiated on 8 Dec 2015 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-0466-2016
- FDA event ID
- 72811
- Recalling firm
- Synvasive Technology, El Dorado Hills, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Dec 2015
- FDA classified
- 22 Dec 2015
- Reported
- 30 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 8 Dec 2015 | Recall initiated by company | |
| 22 Dec 2015 | Classified by FDA | +14 days |
| 30 Dec 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description: STRYK_76542K_19X75X1.27T General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures
Where it was distributed
US Distribution to one location each in CT, MA and CA.
Questions about this recall
Why was it recalled?
Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.
Which lots are affected?
Synvasive Part number: 11-4770; Part number: 19075127YT1; Lot numbers: 45104 and 43054.
Where was it sold?
US Distribution to one location each in CT, MA and CA.
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 Saw Blade -Cutting xintended recalled | Synvasive Technology | Labeling Errors | AL, NY |
| 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 3,110| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |
| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |