FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2600-2018
- Recalling firm
- Encore Medical, Lp
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-06-26
- Posted
- not on file
- Terminated
- 2023-08-22
- 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. ALL ACTIVITIES OUTLINED ABOVE SHOULD BE COMPLETED BY JULY 30, 2018. If you have any questions, please call (512) 834-6255 or by email to teffany.hutto@djoglobal.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.
- Lot, serial or model codes
- 804-99-129 Vendor Lot #22747003
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28