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STRYKER GmbH FDA Inspection Record

FEI 3002807830 · Inspections, Form 483s, warning letters and import refusals

STRYKER GmbH is an FDA-registered facility (FEI 3002807830) located in SELZACH Solothurn, CH. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 27, 2025: Voluntary Action Indicated (VAI)
Inspections on record
4 (3 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
21, latest Jul 1, 2026

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 27, 2025Voluntary Action Indicated (VAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Feb 25, 2016Voluntary Action Indicated (VAI)No citations listed
Sep 22, 2011No Action Indicated (NAI)No citations listed
Nov 6, 2008Voluntary Action Indicated (VAI)No citations listed

Recalls

Showing the 10 most recent of 21 recalls. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Jul 1, 2026Class IIZ-2827-2026Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. and 6 more products
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
May 28, 2025Class IIZ-1914-2025Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number…
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
May 22, 2025Class IIZ-1939-2025Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. and 1 more product
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and…
Mar 28, 2025Class IIZ-1620-2025Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S; and 1 more product
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
May 9, 2024Class IIZ-2219-2024Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
Feb 7, 2023Class IIZ-1191-2023stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external…
Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized…
Mar 28, 2022Class IIZ-1011-2022Smart Toe II Intramedullary Arthrodesis Implant
The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for…
May 27, 2021Class IIZ-2170-2021Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number… and 1 more product
The devices have a different inner diameter than the diameter specified on the outer box label.
Sep 25, 2020Class IIZ-0457-2021Osteosynthesis Compression Staple EasyClip
The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09…
May 7, 2020Class IIZ-2373-2020Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product… and 14 more products
Seal integrity of the blister pack may be compromised and sterility cannot be assured

FDA record score

43 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

24 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMar 27, 20256 x 16
Class II recall Z-2827-2026, this FEI as the recalling firmJul 1, 20264 x 14
Class II recall Z-1914-2025, this FEI as the recalling firmMay 28, 20254 x 14
Class II recall Z-1939-2025, this FEI as the recalling firmMay 22, 20254 x 14
Class II recall Z-1620-2025, this FEI as the recalling firmMar 28, 20254 x 14
Class II recall Z-2219-2024, this FEI as the recalling firmMay 9, 20244 x 0.62.4
Class II recall Z-1191-2023, this FEI as the recalling firmFeb 7, 20234 x 0.62.4
Class II recall Z-1011-2022, this FEI as the recalling firmMar 28, 20224 x 0.62.4
Class II recall Z-2170-2021, this FEI as the recalling firmMay 27, 20214 x 0.251
Class II recall Z-0457-2021, this FEI as the recalling firmSep 25, 20204 x 0.251
Class II recall Z-2373-2020, this FEI as the recalling firmMay 7, 20204 x 0.251
Class II recall Z-0780-2020, this FEI as the recalling firmDec 5, 20194 x 0.251
Class II recall Z-0781-2020, this FEI as the recalling firmNov 21, 20194 x 0.251
Class II recall Z-2412-2019, this FEI as the recalling firmJul 25, 20194 x 0.251
Class II recall Z-1848-2019, this FEI as the recalling firmApr 30, 20194 x 0.251
Class II recall Z-0980-2019, this FEI as the recalling firmJan 21, 20194 x 0.251
Class II recall Z-0288-2019, this FEI as the recalling firmAug 28, 20184 x 0.251
Class II recall Z-3240-2018, this FEI as the recalling firmJul 26, 20184 x 0.251
Class II recall Z-2884-2018, this FEI as the recalling firmJun 27, 20184 x 0.251
Class II recall Z-2244-2018, this FEI as the recalling firmMay 4, 20184 x 0.251
Class II recall Z-2393-2018, this FEI as the recalling firmApr 27, 20184 x 0.251
Class II recall Z-1526-2018, this FEI as the recalling firmMar 12, 20184 x 0.251
Inspection classified VAIFeb 25, 201610 years or older, so it adds no points0
Inspection classified VAINov 6, 200810 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Stryker GmbH
Location
SELZACH Solothurn (CH)
Source
device

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.