Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0084-2017.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0084-2017.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Zimmer Biomet, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0084-2017.
Zimmer Biomet, Inc.
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Zimmer Biomet, Inc. Recall FAQ
Zimmer Biomet, Inc. is the subject of a medical implants safety report: Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product.... The notice was published on August 9, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 31 units are potentially affected.