Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 19, 2016
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.
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 tar…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zimmer Biomet, Inc. recalled Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthoped… - a moderate-severity action.
Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthoped… was recalled by Zimmer Biomet, Inc. in October 19, 2016. Reason: Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as…. Check the official notice for the remedy. Verify recall #Z-0083-2017 with the FDA Devices before acting.
The recall
Zimmer Biomet, Inc. issued this moderate-severity FDA Devices recall-Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as….
- Moderate
- severity level
- 31 units
- affected scope
- Class II
- classification
- October 19, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0083-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0083-2017) was formally reported on October 19, 2016, with the manufacturer initiating the action on August 9, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer Biomet, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 31.
The documented reason for this recall is: 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 slee… Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of: MI, UT, SD, OH, WA, KS, MO, NJ, GA, and TX.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
31
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0083-2017 |
| Date reported | October 19, 2016 |
| Date initiated | August 9, 2016 |
| Recalling firm | Zimmer Biomet, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 31 |
| Distribution | US Nationwide Distribution in the states of: MI, UT, SD, OH, WA, KS, MO, NJ, GA, and TX. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0083-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zimmer Biomet, Inc.. Units affected: 31.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2016. Severity: Moderate. Recall number: Z-0083-2017.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of: MI, UT, SD, OH, WA, KS, MO, NJ, GA, and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0083-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 19, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.