Encore Medical Recalls Empowr PS Knee System Box Cut Guides
Encore Medical is recalling 162 Empowr PS Knee System Box Cut Guides because femoral chipping occurred during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a specific surgical complication (femoral chipping) without reporting hospitalizations or deaths, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Encore Medical, Lp is recalling 162 units of the Empowr PS Knee System Box Cut Guide. This medical device 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 occurred in surgery while chiseling for bone removal in the box area. The affected units were distributed nationwide.
The specific lot codes associated with this recall are 202351L01, 202351L02, 202351L03, 202351L04, 202351L05, 202351L06, 202351L07, 202351L08, 202351L09, 203779L09, 202351L10, 203779L10, and 203203L01. Healthcare providers should stop using these devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
- Manufacturer
- Encore Medical, Lp
- Affected units
- 162
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 (13)
- 202351L01
- 202351L02
- 202351L03
- 202351L04
- 202351L05
- 202351L06
- 202351L07
- 202351L08
- 202351L09
- 203779L09
- 202351L10
- 203779L10
- 203203L01
Distribution
Distributed nationwide across the United States.
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