Z-0083-2017Class II

Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical...

Name: Z-0083-2017 Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical...
Creator: Zimmer Biomet, Inc.
Published: 2016-08-09
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-08-09 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix... on 2016-08-09. FDA classified it as Class II and gives the reason as "Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. The old revision tissue...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0083-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-09
Posted: 2016-10-14
Terminated: 2017-03-23
Recalling firm: Zimmer GmbH
Product: Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. These instruments are used in support of the surgery.
Product code: FZX Guide, Surgical, Instrument
Reason for recall: Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. The old revision tissue sleeve has too much clearance with new revision targeting arm. Risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another Recon Targeting Arm or Recon Soft tissue Sleeve is located or while the surgeon completes the procedure by hand.
FDA root cause: Finished device change control
Action: On 8/9/2016, URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions or concerns call the customer call center at 1-800-348-9500 ext 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be sent by email to [email protected].
Quantity in commerce: 31
Distribution: US Nationwide Distribution in the states of: MI, UT, SD, OH, WA, KS, MO, NJ, GA, and TX.
Product codes and lots: Item number: 14-442008 Lot number: 2095181

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0083-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0083-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-13
Z-0084-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-13

Product code FZX

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)