Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 29, 2018
Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and rad
Packages labeled as containing 110mm rods may contain 100mm rods.
Back 2 Basics Direct LLC recalled Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage… - a moderate-severity action.
Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage… was recalled by Back 2 Basics Direct LLC in August 29, 2018. Reason: Packages labeled as containing 110mm rods may contain 100mm rods.. Check the official notice for the remedy. Verify recall #Z-2881-2018 with the FDA Devices before acting.
The recall
Back 2 Basics Direct LLC issued this moderate-severity FDA Devices recall-Packages labeled as containing 110mm rods may contain 100mm rods..
- Moderate
- severity level
- 10 units
- affected scope
- Class II
- classification
- August 29, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2881-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2881-2018) was formally reported on August 29, 2018, with the manufacturer initiating the action on June 29, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Back 2 Basics Direct LLC is listed as the recalling firm, operating out of Independence, OH. Federal records list the affected scope as 10.
The documented reason for this recall is: Packages labeled as containing 110mm rods may contain 100mm rods. Distribution data in the federal record shows the product reached: The products were distributed to the following US states: OH.. 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
10
Related Recalls
6
3 from same agency
Product description
Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Reason for recall
Packages labeled as containing 110mm rods may contain 100mm rods.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2881-2018 |
| Date reported | August 29, 2018 |
| Date initiated | June 29, 2018 |
| Recalling firm | Back 2 Basics Direct LLC |
| Firm location | Independence, OH |
| Affected scope | 10 |
| Distribution | The products were distributed to the following US states: OH. |
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-2881-2018) 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? ▼
Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).. Recalled by Back 2 Basics Direct LLC. Units affected: 10.
Why was this product recalled? ▼
Packages labeled as containing 110mm rods may contain 100mm rods.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2018. Severity: Moderate. Recall number: Z-2881-2018.
Where was the recalled product distributed? ▼
Distribution: The products were distributed to the following US states: OH..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2881-2018) 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 August 29, 2018. 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.