FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
- Recall number
- Z-1312-2016
- Recalling firm
- Synthes (USA) Products LLC
- Product
- Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
- Status
- Terminated
- Initiated
- 2016-02-16
- Posted
- not on file
- Terminated
- 2016-12-07
- Reason
- DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which are a part of the Synthes 4.5 mm LCP Proximal Tibia Plate System. The Synthes 4.5 mm LCP Proximal Tibia Plate are indicated for the treatment of nonunions, malunions and fractures of the proximal tibia including: simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combi
- Root cause
- Device Design
- Action
- DePuy Synthes sent an Urgent Notice to inform customers that they were initiating a voluntary recall of lot numbers: 1776197, 5706588, 1782340 and 1868678 of the Interlocking Bolt which are part of the Synthes 4.5mm LCP Proximal Tibia Plate System. Customers were asked to review their inventory for the affected lots, call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verifcation Section (page 3 of the letter) identifying that the affected product has been located and return it to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. A copy of the Verification Section of the letter was to be faxed to 866-737-4701 or emailed to: Synthes2856@stericycle.com.
- Quantity
- 42 plate systems
- Distribution
- Nationwide Distribution including AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
- Lot, serial or model codes
- Lot Number# 1776197 (5706588), 1782340 and 1868678 Catalog ID 03.120.027 For lot 1776197, the part is etched with 1776197; the package label documents 5706588.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FZX
- Firm FEI
- 3008812560
- 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