Zimmer Biomet Recalls Phoenix Recon Soft Tissue Sleeve Guide Instruments
Zimmer Biomet is recalling 31 Phoenix Recon Soft Tissue Sleeve Guides due to incompatibility with new revision targeting arms, which may cause 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. The hazard involves a functional incompatibility leading to potential surgical delays or manual completion of procedures, but no injuries or illnesses are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 31 units of the Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm. The affected items are identified by item number 14-442008 and lot number 2095181. These instruments are used in support of the Phoenix Femoral Nail System, which is implanted into the femur for alignment, stabilization, and fixation of fractures.
The recall is due to a design incompatibility between old and new revisions of the soft tissue sleeve and recon targeting arm. 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. This lack of interchangeability means the correct instrument may not be readily available for a procedure.
The affected products were distributed nationwide in the states of Michigan, Utah, South Dakota, Ohio, Washington, Kansas, Missouri, New Jersey, Georgia, and Texas. The risk of encountering the affected product includes the surgeon having to complete the procedure by hand or a delay in surgery greater than 30 minutes while another instrument is located. No injuries or illnesses have been reported in the source text.
The recalled product
- 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 b
- Manufacturer
- Zimmer Biomet, Inc.
- 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: 14-442008 Lot number: 2095181
Distribution
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.
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