DePuy Spine Recalls EXPEDIUM Offset Conical Lock Nut Devices
DePuy Spine, Inc. is recalling 183 EXPEDIUM Offset Conical Lock Nut 8mm devices because they do not mate as intended.
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: The recall is classified as FDA Class II for a medical device with a functional defect (does not mate as intended). Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
DePuy Spine, Inc. is recalling 183 units of the EXPEDIUM Spine System/Synapse System, specifically the EXPEDIUM Offset Conical Lock Nut 8mm (Catalog No. 1754-91-150). The recall involves devices with lot numbers ARNDC6 and ARN DC7.
The recall was initiated because the devices do not mate as intended. This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected devices were distributed in Pennsylvania and in the following foreign countries: Sweden, Belgium, Italy, and Portugal. Healthcare providers and patients should contact DePuy Spine, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
- Manufacturer
- DePuy Spine, Inc.
- Hazard
- Affected units
- 183
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)
- LOT NUMBER: ARNDC6 & ARN DC7
Distribution
Distributed in 1 state:
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