Home / Recalls / Surgical Instrument Service And Savings, Inc. / Z-1640-2013

Z-1640-2013 Class II Terminated

Recalled by Surgical Instrument Service And Savings, Inc. — Redmond, OR

Recall Details

Product Type
Devices
Report Date
July 10, 2013
Initiation Date
May 3, 2013
Termination Date
July 11, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34

Product Description

- 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.

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.

Distribution Pattern

Nationwide Distribution.

Code Information

123263, 122504, 122406, 122592, 122482, 123043, 122289, 122518, 122511.

Other recalls by Surgical Instrument Service And Savings, Inc.

  • Z-1630-2013 Class II — - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 (May 3, 2013)
  • Z-1632-2013 Class II — Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 (May 3, 2013)
  • Z-1627-2013 Class II — -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N (May 3, 2013)
  • Z-1623-2013 Class II — -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF (May 3, 2013)
  • Z-1641-2013 Class II — - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. (May 3, 2013)
  • Z-1643-2013 Class II — - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 1 (May 3, 2013)
  • Z-1629-2013 Class II — - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 12 (May 3, 2013)
  • Z-1625-2013 Class II — -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35m (May 3, 2013)
  • Z-1634-2013 Class II — Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual s (May 3, 2013)
  • Z-1626-2013 Class II — GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needle (May 3, 2013)