FDA Medical Device Recalls (openFDA)
SAFE ORTHOPAEDICS LLC: SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
- Recall number
- Z-1572-2022
- Recalling firm
- SAFE ORTHOPAEDICS LLC
- Product
- SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
- Status
- Completed
- Initiated
- 2022-06-03
- Posted
- not on file
- Terminated
- not on file
- Reason
- The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.
- Root cause
- Labeling Change Control
- Action
- The recall letter was issued on 6/3/2022 via email to the firm's one U.S. customer. The email included a dealer recall letter, dealer response form, and a template letter for notification of any hospitals who received the product from the dealer. The letter requested the products be quarantined and the dealer should contact the hospitals who received the product to notify them of the incorrect patient labels.
- Quantity
- 8 devices
- Distribution
- Distribution was made to MD. There was no government/military distribution.
- Lot, serial or model codes
- KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.
- 510(k) numbers
- ["K201648"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3018359693
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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