CLASS II Device recall · Reported 10 Jul 2013 · FDA Enforcement Report
Accu-pass Suture Shuttle, 70 Degree, Upbend, (Orange) recalled
Surgical Instrument Service And Savings is recalling Accu-pass Suture Shuttle, 70 Degree, Upbend, (Orange), 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-1640-2013
- 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
- Hip & Knee Implants
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
- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289 - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592 Orthopedic manual surgical instrument.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Is Accu-pass Suture Shuttle, 70 Degree, Upbend, (Orange) recalled?
Yes. Surgical Instrument Service And Savings recalled Accu-pass Suture Shuttle, 70 Degree, Upbend, (Orange) on 3 May 2013. The recall is Class II and its status is Terminated. Recall number Z-1640-2013.
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?
123263, 122504, 122406, 122592, 122482, 123043, 122289, 122518, 122511.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |