Synthes 2.5MM Surgical Drill Bits Recalled Due to Unconfirmed Sterility
Synthes (USA) Products LLC is recalling 30 units of 2.5MM sterile surgical drill bits (Lot 77P6506) because sterility cannot be confirmed. Non-sterile surgical instruments pose a risk of surgical site infection if used in 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 an FDA Class II recall of surgical instruments used in invasive orthopedic procedures where sterility cannot be confirmed. While no illnesses or injuries have been reported to date, non-sterile surgical instruments pose a significant and direct risk of serious patient harm through infection.
Plain-English summary
Synthes (USA) Products LLC is recalling 30 units of 2.5MM surgical drill bits (Lot 77P6506, UDI 10886982186324) used in orthopedic surgery. The manufacturer has determined that the products are not sterilized and sterility cannot be confirmed, which violates the critical requirement for surgical instruments intended for sterile use.
The affected drill bits were distributed worldwide, including to facilities in the United States and internationally in Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, and South Africa.
Healthcare facilities and practitioners who have received these drill bits should discontinue use immediately and contact Synthes (USA) Products LLC for return or replacement instructions. Non-sterile surgical instruments used in invasive procedures create a risk of surgical site infection and serious patient harm.
The recalled product
- Product
- 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 30
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: 10886982186324 Lot Number: 77P6506
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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