Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 20, 2016
Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as bac
The label on the outer packaging does not match the product inside and intended use of the device.
Synthes (USA) Products LLC recalled Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-ster… — a moderate-severity action.
Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-ster… was recalled by Synthes (USA) Products LLC in April 20, 2016. Reason: The label on the outer packaging does not match the product inside and intended use of the device.. Check the official notice for the remedy. Verify recall #Z-1392-2016 with the FDA Devices before acting.
The recall
Synthes (USA) Products LLC issued this moderate-severity FDA Devices recall — The label on the outer packaging does not match the product inside and intended use of the device..
- Moderate
- severity level
- 6 units
- affected scope
- Class II
- classification
- April 20, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1392-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1392-2016) was formally reported on April 20, 2016, with the manufacturer initiating the action on February 18, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Synthes (USA) Products LLC is listed as the recalling firm, operating out of West Chester, PA. Federal records list the affected scope as 6 units.
The documented reason for this recall is: The label on the outer packaging does not match the product inside and intended use of the device. Distribution data in the federal record shows the product reached: Distributed in the US: OH and ND. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
6 units
Related Recalls
6
6 from same agency
Product description
Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months or non-operative treatment. The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS Including ClickX) and small stature USS.
Reason for recall
The label on the outer packaging does not match the product inside and intended use of the device.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1392-2016 |
| Date reported | April 20, 2016 |
| Date initiated | February 18, 2016 |
| Recalling firm | Synthes (USA) Products LLC |
| Firm location | West Chester, PA |
| Affected scope | 6 units |
| Distribution | Distributed in the US: OH and ND |
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-1392-2016) 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? ▼
Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months or non-operative treatment. The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS Including ClickX) and small stature USS.. Recalled by Synthes (USA) Products LLC. Units affected: 6 units.
Why was this product recalled? ▼
The label on the outer packaging does not match the product inside and intended use of the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2016. Severity: Moderate. Recall number: Z-1392-2016.
Where was the recalled product distributed? ▼
Distribution: Distributed in the US: OH and ND.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1392-2016) 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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What to do next
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported April 20, 2016.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.