Synthes 1.5MM Surgical Drill Bit Recalled Due to Sterilization Concerns
Synthes has recalled 17 units of 1.5MM surgical drill bits worldwide because the products could not be confirmed as sterilized, posing an infection risk during orthopedic procedures.
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: This is a Class II medical device recall for a surgical instrument that could not be confirmed as sterilized. Although no illnesses or injuries have been reported, the use of non-sterile surgical instruments poses a significant risk of infection. Per the severity rubric, recalls involving high-risk hazards where injury has not yet been reported are scored as High (3).
Plain-English summary
Synthes (USA) Products LLC has recalled 17 units of 1.5MM Drill Bit/QC/85MM sterile surgical drill bits used in orthopedic procedures. The devices, part number 310.15S, have been distributed worldwide including throughout the United States, Canada, Mexico, and 16 other countries.
The recall was issued because the products could not be confirmed as sterilized. Non-sterile surgical instruments pose a risk of infection when used in surgical procedures.
Healthcare facilities that have received these drill bits should stop using them immediately and contact Synthes with any questions. The affected lot number is 19P4364 (UDI: 10886982186034). Patients who may have undergone procedures with these drill bits should consult their healthcare provider if they have concerns about infection risk.
The recalled product
- Product
- 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 17
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)
- UDI: 10886982186034 Lot Number: 19P4364
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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