Recall Z-0044-2011 ยท NBH Accessories, Arthroscopic
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
| Date | Oct 12, 2010 (initiated Apr 29, 2010) |
| Status | Terminated |
| Reason | Endofemoral Aimer tip may separate due to failure of the soldered joint |
| Root cause | Component design/selection |
| Action | Smith & Nephew sent a "Medical Device Recall Information" letter dated April 29, 2010, with an attached "Urgent-Product Recall 1st Notification - Urgent" response form via Federal Express on April 29, 2010, to all customers. An e-mail was sent to the contacts in the identified OUS countries alerting them of the recall. ( Note: On June 24, 2010, the firm expanded the recall to include 4 additional catalog numbers 7220l713F, 72201714F, 72201715F, 722017l6F that are refurbished and one additional lot number to catalog Number: 72201714.) The letter described the product, problem and action to be |
| Quantity | 704 units |
| Distribution | Worldwide distribution: USA and countries including: Australia, Austria, Belgium, Brazil, Canada, Costa Rica, Denmark. Dubal, Finland, France. Germany, Greece, Hong Kong, India, Italy, Japan, Malaysia, Netherlands. Norway, Portugal, Puer To Rico, Singapore. South Africa, Spain. Sweden, Switzerland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.