Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 61 of 63
Spinal Solutions, LLC
Class II Terminated
50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use a...
Reason: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not ...
Z-1410-2013 June 5, 2013 Murrieta, CA
Orthopedic Alliance LLC
Class II Terminated
Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr ...
Reason: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were n...
Z-1386-2013 June 5, 2013 Murrieta, CA
Spinal Solutions, LLC
Class II Terminated
45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use a...
Reason: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not ...
Z-1409-2013 June 5, 2013 Murrieta, CA
Orthopedic Alliance LLC
Class II Terminated
Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54m...
Reason: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were n...
Z-1383-2013 June 5, 2013 Murrieta, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1237-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1227-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1230-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1235-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1223-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1228-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1226-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1219-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1236-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1218-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1229-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1232-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1220-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1222-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1221-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1225-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1233-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1224-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1231-2013 May 15, 2013 San Jose, CA
Stryker Endoscopy
Class II Terminated
Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30¿ Downward Bend At Proximal End. Suction irrigator tips aid in cleaning and clearing the operative site during lapar...
Reason: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Z-1234-2013 May 15, 2013 San Jose, CA
Advanced Sterilization Products
Class II Terminated
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization S...
Reason: Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration ...
Z-1180-2013 May 8, 2013 Irvine, CA