Exactech Shoulder GPS Impactor Handle Recalled for Locking Mechanism Defect
Exactech is recalling 250 units of its Shoulder GPS Impactor Handle due to a defect where the ball and spring in the locking mechanism can dislodge during disassembly or impaction. The defect could affect the device's function during surgical use.
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: This is a Class II FDA recall for a surgical instrument with a known mechanical defect (ball and spring dislodgement from the locking mechanism) that could occur during device disassembly or use. While no injuries or illnesses are reported in the source documentation, the potential for device malfunction during critical surgical procedures justifies a High severity rating as a risk-of-harm product.
Plain-English summary
Exactech, Inc. is recalling the Shoulder GPS Impactor Handle (Catalog #531-07-05) due to a defect in the device's locking mechanism. The ball and spring housed within the locking mechanism can dislodge during disassembly or during impaction, which could impact the handle's performance during use.
The recall affects 250 devices distributed throughout the United States (Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Wisconsin, and Puerto Rico), as well as Australia, France, and Japan. The affected products are identified by Catalog #531-07-05 with lot numbers 154287001, 295878002, and 302331004.
Healthcare facilities and practitioners who have received this product should verify whether they have affected units using the provided catalog number and lot information. Contact Exactech, Inc. for guidance on replacement or corrective measures.
The recalled product
- Product
- Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
- Manufacturer
- Exactech, Inc.
- Affected units
- 250
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 (4)
- Catalog #531-07-05 - Lot numbers: 154287001
- 295878002
- and 302331004
- UDI-DI 10885862542038.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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