CLASS II Device recall · Reported 3 Jun 2020 · FDA Enforcement Report
Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM recalled
Biomet is recalling Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM, distributed nationwide in the US. The recall was initiated on 17 Apr 2020 and the FDA has classified it as Class II.
Check your package
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-2144-2020
- FDA event ID
- 85524
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Apr 2020
- FDA classified
- 28 May 2020
- Reported
- 3 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Apr 2020 | Recall initiated by company | |
| 28 May 2020 | Classified by FDA | +41 days |
| 3 Jun 2020 | 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
Potential presence of elevated endotoxin levels that exceed the specification limit
Product as listed by the FDA
Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.
Questions about this recall
Is Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM recalled?
Yes. Biomet recalled Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM on 17 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2144-2020.
Why was it recalled?
Potential presence of elevated endotoxin levels that exceed the specification limit
Which lots are affected?
Lot Numbers: 1)597000 UDI (01)00880304462489(17)211229(10)597000 2) 502510 UDI (01)00880304475458(17)211229(10)502510 3) 744880 UDI (01)00880304475434(17)220117(10)744880
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.
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.
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