CLASS II Device recall · Reported 2 May 2018 · FDA Enforcement Report

Hinge Coupling Hoffmann LRF recalled by Stryker

Stryker is recalling Hinge Coupling Hoffmann LRF, distributed nationwide in the US. The recall was initiated on 12 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # L23745

Quantity recalled18

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1526-2018
FDA event ID: 79751
Recalling firm: Stryker, Selzach, N/A
Classification: Class II
Status: Terminated
Recall initiated: 12 Mar 2018
FDA classified: 26 Apr 2018
Reported: 2 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

12 Mar 2018	Recall initiated by company
26 Apr 2018	Classified by FDA	+45 days
2 May 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.

Where it was distributed

USA (nationwide) Distribution

Nationwide

Questions about this recall

Is Hinge Coupling Hoffmann LRF recalled?

Yes. Stryker recalled Hinge Coupling Hoffmann LRF on 12 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1526-2018.

Why was it recalled?

The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling

Which lots are affected?

Lot # L23745

Where was it sold?

USA (nationwide) Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Stryker

All 192

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	Pkg., Strykeflow Suction/irrigator Ps recalled by Stryker	Stryker	Packaging Defects	Nationwide
12 Aug 2026Device	CLASS II	Ahto Tube Set With Tip Packaging recalled by Stryker	Stryker	Packaging Defects	Nationwide
12 Aug 2026Device	CLASS II	Pkg., Single Spike Tube Set recalled by Stryker	Stryker	Packaging Defects	Nationwide
12 Aug 2026Device	CLASS II	Ahto Tube Set Packaging recalled by Stryker	Stryker	Packaging Defects	Nationwide
12 Aug 2026Device	CLASS II	Ahto Dual Spike Tube Set Packaging recalled by Stryker	Stryker	Packaging Defects	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide