Encore Medical Recalls AltiVate Reverse Humeral Broach Due to Undersized Feature
Encore Medical is recalling 23 AltiVate Reverse Humeral Broaches because the trial shell mating feature is undersized. The instruments are used with Encore Shoulder prostheses.
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 involves a structural defect in a medical device used during surgery, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Encore Medical, Lp is recalling 23 units of the AltiVate Reverse Humeral Broach, including sizes 10, 14, and 16. These are orthopedic surgical instruments designed for use with the Encore Shoulder prosthesis. The recall is due to a manufacturing defect where the trial shell mating feature on the broach is undersized.
The affected units were distributed throughout the United States to the states of Florida, Pennsylvania, Idaho, California, Ohio, Arizona, Tennessee, Nevada, Washington, Mississippi, Georgia, Massachusetts, Kansas, and Texas. Specific lot codes associated with the recall include 178881L05, 178881L06, 183345L03, 178881L09, 178881L10, 183345L05, 178881L11, 178881L12, and 183345L06.
Healthcare providers and facilities should stop using the affected broaches and contact Encore Medical for further instructions on the recall process.
The recalled product
- Product
- AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
- Manufacturer
- Encore Medical, Lp
- Hazard
- Affected units
- 23
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 (9)
- 178881L05
- 178881L06
- 183345L03
- 178881L09
- 178881L10
- 183345L05
- 178881L11
- 178881L12
- 183345L06
Distribution
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