FDA Recalls Encore Medical Empowr PS Knee System Box Cut Guides
Encore Medical is recalling 436 units of the Empowr PS Knee System Box Cut Guide because the design can cause femoral chipping during 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a surgical instrument defect that has resulted in reported femoral chipping during surgery, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Empowr PS Knee System Box Cut Guide, manufactured by Encore Medical, Lp. The recall affects 436 units distributed in the United States. The product is used to make the housing resection for the post of the posterior stabilized implant during total knee replacement surgery.
The recall was initiated because it was discovered that femoral chipping has occurred in surgery while chiseling for bone removal in the box area. The current design of the box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.
The source text does not specify specific actions for consumers or patients, but the recall is limited to the specific lot codes listed in the agency's documentation.
The recalled product
- Product
- Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
- Manufacturer
- Encore Medical, Lp
- Affected units
- 436
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 (20)
- 202351L01
- 202434L01
- 203779L01
- 202351L02
- 202434L02
- 202351L03
- 202434L03
- 203779L03
- 202351L04
- 202434L04
- 202351L05
- 202434L05
- 202351L06
- 202434L06
- 203779L06
- 202351L07
- 202434L07
- 203779L07
- 202351L08
- 202434L08
Distribution
Distribution scope not specified by the agency.
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