Recall Z-2600-2018 ยท LRO General Surgery Tray
Encore Medical, Lp
Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrumentation by end users.
| Date | Jun 26, 2018 |
| Status | Terminated |
| Reason | A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible. |
| Root cause | Process control |
| Action | The firm, DJO LLC, sent an "URGENT FIELD SAFETY NOTICE" letter dated 6/26/2018 to its direct accounts by email on 06/26/2018. The letter described the product, problem and actions to be taken. The customers were instructed to return product; contact Customer Service as soon as possible to request an RMA for return and exchange of the full instrument set; and to coordinate the exchange of products with Customer Service. If you do not have these instrument sets or the number of sets identified above, you are required to complete the attached form and email it to sandra.busick@djdoglobal.com. |
| Quantity | 30 units |
| Distribution | US Distribution to states of; AZ, CA, CO, FL, IN, NJ, NY, NV, MI, MN, MO, OH, RI, SC, TN, TX, UT and WA and country of; Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.