FDA Medical Device Recalls (openFDA)
Synthes USA HQ, Inc.: Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
- Recall number
- Z-0905-2013
- Recalling firm
- Synthes USA HQ, Inc.
- Product
- Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
- Status
- Terminated
- Initiated
- 2013-01-11
- Posted
- 2013-03-01
- Terminated
- 2015-08-31
- Reason
- It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
- Root cause
- Device Design
- Action
- The firm, Synthes (USA) sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firmat 610-719-5450 for questions regarding this notice.
- Quantity
- 18
- Distribution
- Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
- Lot, serial or model codes
- Part number 487.967 - Lot numbers 7883454, 3808876, 7824423, 3800758, 3817116, 3794466
- 510(k) numbers
- ["K010690"]
- PMA numbers
- not on file
- Product code
- DZL
- 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