DJO EMPOWR Knee Punch Handle Tip May Break During Surgery
Encore Medical is recalling DJO EMPOWR Knee Punch Handles due to a manufacturing defect that may cause the handle tip to break during surgery, potentially disrupting the procedure.
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 3/5 (High).
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: This is an FDA Class II recall of a surgical instrument where the handle tips may break due to inadequate heat treatment during manufacturing. While the defect poses a risk of surgical disruption, no injuries or hospitalizations have been reported, which per the severity rubric limits the score to 3 (High).
Plain-English summary
Encore Medical, LP is recalling the DJO EMPOWR Knee Punch Handle (REF: 801-05-040). The recall affects 406 units distributed throughout the United States.
The knee punch handle tips may break during surgery due to lack of heat treatment in the manufacturing process. This defect could lead to disruption of the surgical procedure.
Affected units can be identified by lot number or UDI-DI 00190446238881.
The recalled product
- Product
- DJO EMPOWR Knee Punch Handle, REF: 801-05-040
- Manufacturer
- Encore Medical, LP
- Affected units
- 406
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)
- UDI-DI: 00190446238881
- Lots: 305197L02D
- 305197L02E
- 318871L10D
- 318871L10E
- 305197L02B
- 305197L02C
- 318871L10B
- 318871L10C
- 325045L17A
- 325045L17B
- 325045L17C
- 305197L02
- 318871L10
- 325045L17
- 327669L03
- 331146L01
- 332158L06
- 334314L04
- 336735L04
Distribution
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