The Recall Desk
ModerateFDA (Devices)·Z-0084-2017·Announced 2016-10-19

Zimmer Biomet Recalls Phoenix Recon Targeting Arm Surgical Instruments

Zimmer Biomet is recalling 31 Phoenix Recon Targeting Arm surgical instruments because old and new revisions are not interchangeable, potentially causing surgical delays.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a risk of surgical delay or manual completion of the procedure rather than direct physical injury or death, fitting the Moderate severity criteria for low-risk operational issues.

Plain-English summary

Zimmer Biomet, Inc. is recalling 31 units of the Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm. The recall is due to a design incompatibility where old revisions of the soft tissue sleeve and recon targeting arm are not interchangeable with new revisions. Specifically, the new revision tissue sleeve will not fit into the old revision targeting arm, and the old revision tissue sleeve has too much clearance with the new revision targeting arm.

The affected products were distributed nationwide in the states of Michigan, Utah, South Dakota, Ohio, Washington, Kansas, Missouri, New Jersey, Georgia, and Texas. The specific item number is 14-442018, and the affected lot numbers are 290610, 290620, and 386780. These instruments are used in support of surgery for the Phoenix Femoral Nail System, which is implanted into the femur for alignment, stabilization, and fixation of fractures.

The primary risk associated with using the affected products is that the correct instrument may not be readily available for the procedure. This could cause the surgeon to complete the procedure by hand or result in a delay in surgery of greater than 30 minutes while another instrument is located. Healthcare facilities should contact Zimmer Biomet for further instructions on how to return or replace the affected units.

The recalled product

Product
Phoenix Recon Targeting Arm 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 tra
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
31

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Item number: 14-442018 Lot number: 290610 290620 386780

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Zimmer Biomet, Inc.

See all →

Same hazard · surgical delay

See all →