Exactech Recalls Equinoxe Reverse Shoulder Screw Kits Due to Disengaged Heads
Exactech, Inc. is recalling 2,278 Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kits because disengaged screw heads may not be retained in the screwdriver.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Exactech, Inc. is recalling 2,278 units of the Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit. The recall was initiated because a disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
The affected products are identified by Catalog No. 320-20-00 and Unique Device Identifier 10885862086518. The recall covers serial ranges 4410696-4410819, 4415393-4415492, 4418789-4418888, 4422658-4423007, 4423542-4423591, 4424509-4424558, 4458153-4458252, 4458303-4458352, 4461732-4461806, 4464592-4464691, 4467733-4467824, 4471099-4471298, 4485494-4485543, 4488224-4488260, 4504738-4504987, 4513150-4513199, 4513250-4513299, 4517116-4517215, 4519806-4520005, 4533291-4533390, and 4542043-4542092.
The products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and to specific states and international countries. Healthcare providers and patients should check their inventory and patient records for these specific serial numbers. If the product is found, it should be removed from use and returned to Exactech, Inc. according to their instructions.
The recalled product
- Product
- Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
- Manufacturer
- Exactech, Inc.
- Affected units
- 2,278
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 No. 320-20-00
- Unique Device Identifier 10885862086518
- Serial Range 4410696-4410819
- 4415393-4415492
- 4418789-4418888
- 4422658-4423007
- 4423542-4423591
- 4424509-4424558
- 4458153-4458252
- 4458303-4458352
- 4461732-4461806
- 4464592-4464691
- 4467733-4467824
- 4471099-4471298
- 4485494-4485543
- 4488224-4488260
- 4504738-4504987
- 4513150-4513199
- 4513250-4513299
- 4517116-4517215
Distribution
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