CLASS II Device recall · Reported 24 Apr 2013 · FDA Enforcement Report
The Oxford Partial Knee recalled by Synvasive Technology
Synvasive Technology is recalling The Oxford Partial Knee, distributed nationwide in the US. The recall was initiated on 14 Mar 2013 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-1127-2013
- FDA event ID
- 64646
- Recalling firm
- Synvasive Technology, El Dorado Hills, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Mar 2013
- FDA classified
- 16 Apr 2013
- Reported
- 24 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 14 Mar 2013 | Recall initiated by company | |
| 16 Apr 2013 | Classified by FDA | +33 days |
| 24 Apr 2013 | 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
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Product as listed by the FDA
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 reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
Where it was distributed
USA Nationwide Distributor including the state of IN
Questions about this recall
Is The Oxford Partial Knee recalled?
Yes. Synvasive Technology recalled The Oxford Partial Knee on 14 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-1127-2013.
Why was it recalled?
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Which lots are affected?
Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.
Where was it sold?
USA Nationwide Distributor including the state of IN
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.
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 | Zimmer Oscillating Flat - TS ST Hub recalled by Synvasive Technology | Synvasive Technology | Foreign Material | CA, CT, MA |
| Device | CLASS II | Product is recalled by Synvasive Technology | Synvasive Technology | Labeling Errors | Nationwide |
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 | Nitrosamine Impurity | 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) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |