The Recall Desk
ModerateFDA (Devices)·Z-1127-2013·Announced 2013-04-24

Synvasive Oxford Partial Knee Resection Blades Recalled for Incorrect Component

Synvasive Technology is recalling 100 kits of Oxford Partial Knee Resection Procedure 3 Packs because they contained the incorrect surgical blade.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries were reported, and the hazard is a component error (incorrect blade) rather than a high-risk pathogen or structural defect causing harm.

Plain-English summary

Synvasive Technology Inc is recalling 100 kits of the Oxford Partial Knee Resection Procedure 3 Pack CEMENTED. The product, identified by Biomet Product code 506076 and Lot 829182, was distributed nationwide in the United States, including the state of Indiana.

The recall was initiated because the product was received from Synvasive Technology containing the incorrect blade. The product is a set of three surgical saw blades used to resect damaged cartilage and/or bone in orthopedic reconstructive procedures such as partial knee replacements.

Healthcare providers and facilities that have received this product should stop using it and contact Synvasive Technology for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
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
Affected units
100

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Biomet Product code: 506076
  • Lot 829182. Synvasive Part Number: 11-3629.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Synvasive Technology Inc

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