Orthopedic › ProstheticFastener, Fixation, Biodegradable, Soft Tissue

Endofix

SCR Endo-FIX L 7X20MM Bioabs.intf.

Registry build 21.09.26
2manufacturers in China registered for this device type
2catalogue numbers in this listing
10510(k) clearances naming this product code
40recalls on this code

Who Else Makes It

All of them in Shanghai.

Chinese manufacturers registered for FDA product code MAI
Manufacturer City Province Registered as Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38

Record

Regulatory record for Endofix
Listed by Smith & Nephew, Inc., United States
FDA product code MAI
Device type Fastener, Fixation, Biodegradable, Soft Tissue
Device class Class 2
Regulation 21 CFR 888.3030
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k) K984320
Record published 2016-04-12
Record revised 2024-01-03 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Distribution end date 2022-03-17

Catalogue Numbers

Catalogue numbers for Endofix
Catalogue number Size Status
7207480 In distribution
7207479 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Arthrex® Arthrex, Inc. 545
Fix2Lock Osteonic Co., Ltd. 118
Delta Stryker Leibinger Gmbh & Co. KG 110
Reunite Screw System Biomet Orthopedics 85
ComposiTCP S.B.M 61
ActivaScrew™ Interference Bioretec Ltd. 54
Ligafix S.B.M 40
Twinfix Smith & Nephew, Inc. 28
Biosure Smith & Nephew, Inc. 27
TorqLoc Interference Bioretec Ltd. 27
FiberFIX Nanova BIO Materials Inc 25
AlphaVent Stryker GmbH 23

Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K193558 2020-03-18
K151105 2015-07-28
K143172 2015-02-04
K142948 2015-01-13
K123393 2013-04-11
K101459 2011-01-27
K093844 2010-04-01
K032197 2003-08-08
K011985 2001-11-02
K011299 2001-06-27

Recalls

40 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2021-04-08 Class II Process control Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw 2 units US and 193 units OUS. 195 units WW 2022-06-22
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)
2020-09-09 Class II Equipment maintenance Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch 263,874 (total)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer