Offset Cup Impactor Surgical Instruments Recalled for Weld Fracture
INCIPIO DEVICES is recalling 100 units of Offset Cup Impactor surgical instruments (Lot 24A0087) because the TIG weld does not meet specifications and has fractured. These instruments are used in hip surgery to position acetabular cup implants.
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 with a reported structural defect (TIG weld fracture). It qualifies as High severity as a risk-of-harm product used in surgical procedures where injury has not yet been reported, but the potential for surgical complications is significant.
Plain-English summary
The recalled product is the Offset Cup Impactor with a 3/8-16 interface, a reusable surgical instrument manufactured by INCIPIO DEVICES. It is used during hip surgery to position and place acetabular cup implants. The recall affects 100 units distributed nationwide in Tennessee, identified by lot number 24A0087.
The recalled lot does not meet specifications because the TIG weld on these instruments is defective. Fractures of the TIG weld have been reported in the affected units.
Healthcare facilities and medical professionals who received these instruments should immediately stop using them and contact INCIPIO DEVICES regarding recall procedures.
The recalled product
- Product
- Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
- Manufacturer
- INCIPIO DEVICES
- Affected units
- 100
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 (3)
- Product Reference No.: 50341105
- UDI-DI: 07630055304735
- Lot No.: 24A0087.
Distribution
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