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.
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 is classified as FDA Class II, and the hazard involves a structural defect (incorrect screw length) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Exactech, Inc. is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, 4.5 x 18 mm. The recall involves 125 devices that were distributed domestically across 23 US states and internationally to 11 countries.
The recall was initiated because the kits may contain a screw of incorrect length. The source text does not specify the exact nature of the length discrepancy or report any specific injuries or illnesses associated with the use of these devices.
Patients who have received this implant should contact their healthcare provider for evaluation. The recall covers specific serial numbers ranging from S072858 to S072998, with some gaps in the sequence.
The recalled product
- Product
- Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
- Manufacturer
- Exactech, Inc.
- Affected units
- 125
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: 320-20-18 Serial Numbers: S072858
- S072859
- S072860
- S072861
- S072862
- S072863
- S072864
- S072865
- S072866
- S072867
- S072868
- S072869
- S072870
- S072871
- S072872
- S072873
- S072874
- S072875
- S072876
- S072877
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.
See all 2 products in this recall →Related recalls
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