Encore Medical Recalls Flexible Drill Shafts Due to Manufacturing Error
Encore Medical is recalling 21 Flexible Drill Shafts because a manufacturing error may prevent the shaft from capturing the drill bit pin, potentially causing the bit to come loose 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 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: The recall involves a medical device with a risk of harm (adverse patient reaction/revision surgery) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Encore Medical, L.P. is recalling 21 units of the Flexible Drill Shaft, FMP Acetabular System Instrumentation (REF 803-05-239, Lot # 262667L01). The recall was initiated due to a manufacturing error where the drill bit shaft is unable to properly capture the drill bit pin.
The affected products were distributed in the United States to the states of Mississippi, New York, Missouri, Oklahoma, Utah, and Arizona. If the drill bit shaft fails to capture the pin, the drill bit could come loose during use. This failure could result in a delay in surgery or an adverse patient reaction that may require a revision surgery.
Healthcare facilities and consumers who have this product should stop using it immediately and contact Encore Medical, L.P. for instructions on return or replacement. No specific dates or additional distribution details are provided in the source text.
The recalled product
- Product
- Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
- Manufacturer
- Encore Medical, Lp
- Affected units
- 21
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)
- Lot # 262667L01
Distribution
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