CLASS II Device recall · Reported 10 Jul 2013 · FDA Enforcement Report
Large Tear Cross Cut Rasp recalled by Surgical Instrument Service
Surgical Instrument Service And Savings is recalling Large Tear Cross Cut Rasp, distributed nationwide in the US. The recall was initiated on 3 May 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1634-2013
- FDA event ID
- 65205
- Recalling firm
- Surgical Instrument Service And Savings, Redmond, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 May 2013
- FDA classified
- 1 Jul 2013
- Reported
- 10 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 3 May 2013 | Recall initiated by company | |
| 1 Jul 2013 | Classified by FDA | +59 days |
| 10 Jul 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument for general use
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it recalled?
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Which lots are affected?
122347
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
21 other products · FDA event 65205This product is part of a recall event; the main page for the event is Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F recalled.
More recalls from Surgical Instrument Service And Savings
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| Device | CLASS II | Cannulated Drill Bit for Mini TightRope recalled | Surgical Instrument Service And Savings | Sterility | Nationwide |
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| Device | CLASS II | Harmonic ACE Ergonomically-Enhanced Curved Shear recalled | Surgical Instrument Service And Savings | Sterility | Nationwide |
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| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
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| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |