Surgical Instrument Service And Savings Recalls Orthopedic Drill Bits
Surgical Instrument Service And Savings, Inc. is recalling 10 orthopedic drill bits because the sterile barrier seal was compromised, allowing product to fall out of the pouch.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a compromised sterile barrier without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling 10 units of orthopedic manual surgical instruments, specifically various drill bits. The affected products include the Cannulated Drill Bit for Mini TightRope, Drill Bit Straight Shank, Drill Bit w/Depth Mark, Fast Cutting Drill Bit, and Midas Rex Metal Cutting Drill Bit.
The recall was initiated because the seal that maintains a sterile barrier for these reprocessed medical devices became compromised. This defect allowed the product to fall out of the pouch, potentially compromising the sterile status of the instruments.
The affected units were distributed nationwide. Consumers and healthcare facilities should stop using these products and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- - Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0…
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Affected units
- 10
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 (4)
- 122347
- 122289
- 122322
- 122511.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Surgical Instrument Service And Savings, Inc. 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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