Encore Medical, LP is recalling 70 units of the Reverse Prosthesis Shoulder System Locking Bone Screws because some packages labeled as 5mm x 30mm screws may actually contain 3.5mm x 30mm screws. This manufacturing error involves screws with Lot number 835C2074 and an expiration date of March 9, 2029. Using the incorrect, smaller screw during surgery could lead to inadequate fixation of the prosthesis or surgical delays while a correct replacement is located.
The use of an incorrectly sized 3.5mm screw when a 5mm screw is required can result in the shoulder implant not being properly secured to the bone. This inadequate fixation may lead to device failure, loss of mobility, or the need for additional corrective surgery.
Manufacturer corrective action and medical consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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