Providence Medical Technologies recalls Ally Bone Screws (PD 32 601 and PD 32 602 models) due to potential dimensional manufacturing errors that could pose safety risks during bone reconstruction procedures.
There may be dimensional manufacturing error that represents a potential safety risk to patients.
Providence Medical Technologies is recalling Ally Bone Screws (PD 32 601 and PD 32 602 models) because they may have dimensional manufacturing errors that could cause safety risks during bone surgery. This recall affects patients who have received these screws for bone reconstruction or joint fusion procedures.
The screws may have dimensional manufacturing errors that could lead to improper fit during bone surgery. This might cause complications like improper bone alignment or failure to hold the bone fragments together.
Patients who received Ally Bone Screws (PD 32 601 - 10mm and PD 32 602 - 12mm) for bone reconstruction, osteotomy, or joint fusion procedures are most at risk. These screws were sold through medical suppliers with specific lot numbers.
Check for model numbers PD 32 601 (10mm) or PD 32 602 (12mm) with lot numbers 046164, 045375, 045646, 045647, or 046313. These screws were sold as single-use medical devices for bone reconstruction procedures.
Verify the model number and lot number on the screw package to confirm if it is part of the recall.
The recall is due to potential dimensional manufacturing errors that could pose safety risks during bone reconstruction procedures.
PD 32 601 (10mm) with lot number 046164 and PD 32 602 (12mm) with lot numbers 045375, 045646, 045647, and 046313.
The recall does not require immediate discontinuation; however, you should check the product details to confirm if it is affected.
We’ve drafted a message you can send Providence Medical Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-2428-2020 — Providence Medical Technologies Providence Medical Technologies Hello, I own a Providence Medical Technologies that is covered by recall Z-2428-2020 from Providence Medical Technologies. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
