Surgical Instrument Service And Savings Recalls 73 Medical Devices with Compromised Sterile Seals
Surgical Instrument Service And Savings, Inc. is recalling 73 surgical instruments and accessories because their sterile seals may be 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 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: The recall involves a risk-of-harm product (compromised sterile barrier) where injury has not yet been reported, which aligns with the 'High' severity criteria for medical devices.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling 73 units of surgical instrument motors, accessories, and attachments, including various oscillating and sagittal saw blades, drill bits, and burs. The recall covers specific lots identified by codes such as 122590, 123263, and 122347, among others. The products were distributed nationwide.
The recall was initiated because the seal that maintains a sterile barrier for these reprocessed medical devices became compromised. This defect may allow the product to fall out of the pouch, potentially compromising the sterile integrity of the instruments.
Healthcare facilities and consumers who possess these specific surgical instruments should stop using them and contact the recalling firm for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289 - Hall MicroChoice, Oscillating Blade, Fine, Flat, Stainless…
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Affected units
- 73
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 (15)
- 122590
- 123263
- 122347
- 122454
- 122490
- 122631
- 122289
- 123353
- 122609
- 122465
- 122440
- 122429
- 122447
- 122647
- 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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