Recall Z-1674-2015— DePuy Spine, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Spine, Inc., initiated 2015-04-21, terminated 2018-10-03. It names 3 FDA 510(k) clearances: K142460, K111136, K101070. Product: EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467. Reason: Device does not mate as intended..
- Recalling firm
- DePuy Spine, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-21
- Terminated
- 2018-10-03
- Firm location
- Raynham, MA, United States
510(k) clearances named in this recall
3 on FDA's record- K142460 — EXPEDIUM Spine System/Synapse System
- K111136 — EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
- K101070 — EXPEDIUM SPINE SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
Reason for recall
Device does not mate as intended.
Data sourced from openFDA. This site is unofficial and independent of the FDA.