Encore Medical Recalls AltiVate Humeral Socket Shell Trial Due to Assembly Issues
Encore Medical is recalling 20 units of the AltiVate Humeral Socket Shell Trial because the shell trial has difficulty assembling to the broach and the retaining ring disassembles from the screw.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional assembly defect without reporting any patient injuries, illnesses, or fatalities, fitting the criteria for a moderate severity recall.
Plain-English summary
Encore Medical, Lp is recalling 20 units of the AltiVate Humeral Socket Shell Trial, Part Number 804-06-052, Lot 180052L01. The device is a medical implant component intended for shoulder reconstructive surgery.
The recall was initiated because of a manufacturing defect where the shell trial has difficulty assembling to the broach and the retaining ring disassembles from the screw. This issue could affect the proper use of the trial component during surgical procedures.
The affected units were distributed in the United States to the states of Pennsylvania, Florida, Idaho, and California. Healthcare providers and patients who have received or used this specific lot of the AltiVate Humeral Socket Shell Trial should contact Encore Medical for further instructions on how to proceed.
The recalled product
- Product
- AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of previ
- Manufacturer
- Encore Medical, Lp
- Hazard
- Affected units
- 20
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 (1)
- Lot: 180052L01
Distribution
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