Exactech Recalls Equinoxe Reverse Shoulder Compression Screw Kits
Exactech is recalling Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kits because they may contain screws of incorrect length.
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 involves a medical device with a potential defect (incorrect screw length) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm. The recall involves 149 devices distributed domestically across 23 U.S. states and internationally to 11 countries, including Austria, Australia, Germany, France, Spain, Italy, Japan, the United Kingdom, Luxembourg, the Netherlands, and South Africa.
The recall is being conducted because the kits may contain screws of incorrect length. The specific catalog number is 320-20-22, and the affected serial numbers range from S071601 to S071800, with specific exclusions noted in the agency record.
The source text does not specify the actions consumers or healthcare providers should take, nor does it report any injuries or illnesses associated with the use of these devices.
The recalled product
- Product
- Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 149
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)
- Catalog Number: 320-20-22 Serial Numbers: S071601
- S071602
- S071603
- S071604
- S071605
- S071606
- S071607
- S071608
- S071609
- S071610
- S071611
- S071612
- S071613
- S071614
- S071616
- S071617
- S071618
- S071619
- S071620
- S071621
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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