Raynham, MA, United States
DePuy Spine, Inc. recalls
3 recalls recorded since 2018, most recently on 20 May 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 May 2022
- Reason
- Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton
- Distribution
- Distribution US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1324-2022, Z-1323-2022
- EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) Part Number: CUI8070S
- EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD). Part Number: CUI8060L
Terminated Class II Medical devices
- Recall started
- 8 April 2019
- Terminated
- 12 January 2023
- Reason
- A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
- Distribution
- US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1225-2019, Z-1226-2019
- Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
- Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
Terminated Class II Medical devices
- Recall started
- 15 December 2017
- Terminated
- 13 April 2020
- Reason
- Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.
- Distribution
- International Distribution (outside the U.S.) only: Mexico, Canada, Ireland, Great Britain, Malaysia, Germany, Austria, Colombia, Spain, Austria, Switzerland, Australia, Hungary, Croatia, and Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1300-2018
- Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous deliver
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.