FDA Medical Device Recalls (openFDA)
Synthes USA HQ, Inc.: Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
- Recall number
- Z-0396-2014
- Recalling firm
- Synthes USA HQ, Inc.
- Product
- Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
- Status
- Terminated
- Initiated
- 2012-09-07
- Posted
- 2013-11-26
- Terminated
- 2015-12-18
- Reason
- This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.
- Root cause
- Use error
- Action
- Synthes sent an Urgent: Medical Device Product Removal letter on September 7, 2012, to all affected consignees. Consignees were requested to immediately cease using the product, examine their inventory and remove the parts from inventory. If they had the parts, they were further instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the verification section at the end of the letter and return the verification form. If they did not have the parts, they were requested to complete the verification section at the end of the letter and return the verification form. Consignees with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.
- Quantity
- 745
- Distribution
- Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K113044"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- 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