Synthes Opal Intervertebral Cage Spinal Implant Recall: Sterility Not Confirmed
Synthes is recalling 30 Opal intervertebral cage spinal implants (Lot 427P153) because sterility cannot be confirmed. Patients with these devices should contact their surgeon immediately.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving a risk-of-harm product (a surgically implanted spinal device) where injury has not yet been reported. Sterility assurance failure on surgical implants presents a serious potential hazard, but the source text does not report any illnesses, injuries, or hospitalizations.
Plain-English summary
Synthes (USA) Products LLC is recalling 30 units of the Opal Intervertebral Cage (Part Number 08.803.231S), a medical device surgically implanted in the spine to treat degenerative spine disease. The affected devices have UDI 07611819318489 and Lot Number 427P153.
The devices are being recalled because sterility cannot be confirmed. Intervertebral cages are surgically implanted into the spine, and non-sterile implants pose a risk of serious infection at the surgical site and surrounding tissues.
The affected devices were distributed worldwide, including throughout the United States and internationally to Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, and Taiwan.
Patients who have received one of these devices should contact their surgeon or healthcare provider immediately to discuss potential next steps. The surgeon can determine whether additional monitoring or intervention is necessary based on the patient's individual clinical situation.
The recalled product
- Product
- Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
- Manufacturer
- Synthes (USA) Products LLC
- Category
- Medical Device — Spinal Implant
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 07611819318489 Lot Number: 427P153
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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