FDA Medical Device Recalls (openFDA)
Pioneer Surgical Technology: Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP.
- Recall number
- Z-1457-05
- Recalling firm
- Pioneer Surgical Technology
- Product
- Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP.
- Status
- Terminated
- Initiated
- 2005-07-29
- Posted
- 2005-08-31
- Terminated
- 2005-10-25
- Reason
- The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively.
- Root cause
- Other
- Action
- Distributors were notified via letter dated July 29, 2005 to retrieve all caps from inventory and point of use locations and to return them to Pioneer.
- Quantity
- 5069
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lots 306456, 306457, 306613, 306712, 306713, 306714, 306816, 306817, 306818, 306819, 306820, 306821, 306822, 307526, 307527, 307528, 307667, 307668, 308510, 308938, 310662, 310663, 310664, 310665, 311718, 312169, 519935 and 521042.
- 510(k) numbers
- ["K041156"]
- PMA numbers
- not on file
- Product code
- MVH
- Firm FEI
- 1000115331
- Firm city
- Marquette
- Firm state
- MI
- 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