FDA Medical Device Recalls (openFDA)
Medicrea International: Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
- Recall number
- Z-1156-2020
- Recalling firm
- Medicrea International
- Product
- Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
- Status
- Terminated
- Initiated
- 2019-10-02
- Posted
- not on file
- Terminated
- 2021-02-08
- Reason
- Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter
- Root cause
- Process control
- Action
- Medicrea Issued Voluntary Product Recall dated 10/3/19 stating reason for recall, health risk and action to take: 1. Immediately check your internal inventory and quarantine all subject devices pending return to MEDICREA USA 2. Circulate this notification internally to all interested/affected parties. 3. Inform MEDICREA USA if any of the subject devices have been distributed to other organizations. 4. Please inform M EDICREA of any adverse events concerning the use of the subject devices. Complete the attached customer response form. Contact person for this action is given below: Tim Huntington MEDICREA USA QA Manager Tel : 646-490-2426 Mail : thuntington@medicrea.com
- Quantity
- 14 units
- Distribution
- OH, VA
- Lot, serial or model codes
- Lot Numbers l9B0570; 19B0572
- 510(k) numbers
- K163595
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 1000432246
- Firm city
- Vancia Rillieux La Pape
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28