CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report

Altivate Anatomic(TM) Instrumentation, Pegged Glenoid Trial, Size recalled

Encore Medical is recalling Altivate Anatomic(TM) Instrumentation, Pegged Glenoid Trial, Size, distributed nationwide in the US. The recall was initiated on 29 Jan 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Serial Numbers

Quantity recalled92 units

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-1257-2018
FDA event ID: 79241
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Completed
Recall initiated: 29 Jan 2018
FDA classified: 28 Mar 2018
Reported: 4 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

29 Jan 2018	Recall initiated by company
28 Mar 2018	Classified by FDA	+58 days
4 Apr 2018	Published in enforcement report	+7 days

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

Reason for recall

It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants

Product as listed by the FDA

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All Serial Numbers

Where was it sold?

US 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 79241

This product is part of a recall event; the main page for the event is Altivate Anatomic(TM) Instrumentation, Pegged Glenoid Trial, Size recalled.

Reported	Class	Recall	Company	Reason	Where
4 Apr 2018	CLASS II	Altivate Anatomic(TM) Instrumentation, Pegged Glenoid Trial, Size recalled	Encore Medical	Other	Nationwide
4 Apr 2018	CLASS II	Altivate Anatomic(TM) Instrumentation, Pegged Glenoid Trial, Size recalled	Encore Medical	Other	Nationwide
4 Apr 2018	CLASS II	Altivate Anatomic(TM) Instrumentation, Pegged Glenoid Trial, Size recalled	Encore Medical	Other	Nationwide
4 Apr 2018	CLASS II	Altivate Anatomic(TM) Instrumentation, Pegged Glenoid Trial, Size recalled	Encore Medical	Other	Nationwide

More recalls from Encore Medical

All 99

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Empowr 3d Knee Ins, Ve recalled by Encore Medical	Encore Medical	Packaging Defects	14 states
15 Jul 2026Device	CLASS II	Empowr 3d Knee Ins, Ve recalled by Encore Medical	Encore Medical	Packaging Defects	14 states
4 Mar 2026Device	CLASS II	Empowr 3d Knee Ins, Ve recalled by Encore Medical	Encore Medical	Labeling Errors	Nationwide
4 Mar 2026Device	CLASS II	Reverse Shoulder Prosthesis recalled by Encore Medical	Encore Medical	Labeling Errors	Nationwide
4 Mar 2026Device	CLASS II	Reverse Shoulder Prosthesis recalled by Encore Medical	Encore Medical	Labeling Errors	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