Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 26, 2014
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.
Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Biomet Spine LLC. recalled LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Pro… - a moderate-severity action.
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Pro… was recalled by Biomet Spine LLC. in November 26, 2014. Reason: Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component p…. Check the official notice for the remedy. Verify recall #Z-0220-2015 with the FDA Devices before acting.
The recall
Biomet Spine LLC. issued this moderate-severity FDA Devices recall-Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component p….
- Moderate
- severity level
- 120 units
- affected scope
- Class II
- classification
- November 26, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0220-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0220-2015) was formally reported on November 26, 2014, with the manufacturer initiating the action on March 9, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Biomet Spine LLC. is listed as the recalling firm, operating out of Broomfield, CO. Federal records list the affected scope as 120.
The documented reason for this recall is: Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,. 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
120
Related Recalls
6
3 from same agency
Product description
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.
Reason for recall
Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0220-2015 |
| Date reported | November 26, 2014 |
| Date initiated | March 9, 2011 |
| Recalling firm | Biomet Spine LLC. |
| Firm location | Broomfield, CO |
| Affected scope | 120 |
| Distribution | US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas, |
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-0220-2015) 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? ▼
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.. Recalled by Biomet Spine LLC.. Units affected: 120.
Why was this product recalled? ▼
Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2014. Severity: Moderate. Recall number: Z-0220-2015.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0220-2015) 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 November 26, 2014. 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.