Food, drugs, devices › Synvasive Technology Inc
Device recall: The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System
FDA enforcement event 64646 is a device recall by Synvasive Technology Inc of El Dorado Hills, CA, initiated 14 Mar 2013 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 13 Jan 2014. Initiation: voluntary: firm initiated. Synvasive Technology Inc has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Synvasive Technology Inc, El Dorado Hills, CA.
Reason for recall
"Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade."
Distribution
"USA Nationwide Distributor including the state of IN"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1127-2013 | The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic… | 100 kits | Class II | Terminated | 24 Apr 2013 |
Context
Other enforcement events for Synvasive Technology Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Jul 2018 | ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. | Device | Class II | 1 |
| 8 Dec 2015 | Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No | Device | Class II | 1 |
| 2 Apr 2013 | Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under | Device | Class II | 1 |
All 4 events for Synvasive Technology Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "USA Nationwide Distributor including the state of IN"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Jan 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.