Z-2600-2018Class II

Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container...

Name: Z-2600-2018 Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container...
Creator: Encore Medical, Lp
Published: 2018-06-26
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2018-06-26 / Terminated / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of 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... on 2018-06-26. FDA classified it as Class II and gives the reason as "A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2600-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-26
Posted: 2018-08-02
Terminated: 2023-08-22
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.
Product code: LRO General Surgery Tray
Reason for recall: A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: 804-99-129 Vendor Lot #22747003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2600-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2600-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-08-02

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)