Encore Medical Recalls EMPOWR Partial Knee Peg Drill Guide
Encore Medical is recalling 28 units of the EMPOWR Partial Knee Peg Drill Guide because the drill shaft may bind during use, potentially delaying surgery.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The source text explicitly states the primary risk is a 'delay in surgery' rather than direct patient injury or death, fitting the criteria for a moderate severity recall involving a procedural delay or theoretical risk without reported harm.
Plain-English summary
Encore Medical, LP is recalling 28 units of the EMPOWR Partial Knee Peg Drill Guide, Model 800-06-007. The recall covers all lot numbers of this specific model.
The recall was initiated due to issues with the peg preparation steps, specifically when drilling the Femoral posterior peg. The shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances are contributing to this situation. If this issue recurs, there is a potential for a delay in surgery.
The affected units were distributed in the United States to Arizona, California, Florida, Georgia, Illinois, Indiana, Michigan, Minnesota, New York, Texas, Virginia, and Washington. There are no overseas consignees. Healthcare providers should stop using the affected devices and contact Encore Medical for further instructions.
The recalled product
- Product
- EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
- Manufacturer
- Encore Medical, LP
- Affected units
- 28
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 (1)
- all lot numbers
Distribution
Part of a larger recall action
This product is one of 2 recalled by Encore Medical, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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