CLASS II Device recall · Reported 17 Jun 2020 · FDA Enforcement Report
A.l.p.s. Proximal Humerus Plating System Low Plate Right 14 Hole recalled
Biomet is recalling A.l.p.s. Proximal Humerus Plating System Low Plate Right 14 Hole, distributed nationwide in the US. The recall was initiated on 14 May 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-2318-2020
- FDA event ID
- 85701
- Recalling firm
- Biomet, Miami, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 May 2020
- FDA classified
- 9 Jun 2020
- Reported
- 17 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 May 2020 | Recall initiated by company | |
| 9 Jun 2020 | Classified by FDA | +26 days |
| 17 Jun 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Distributed to the field without having completed design history files or design transfer activities
Product as listed by the FDA
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
Questions about this recall
Is A.l.p.s. Proximal Humerus Plating System Low Plate Right 14 Hole recalled?
Yes. Biomet recalled A.l.p.s. Proximal Humerus Plating System Low Plate Right 14 Hole on 14 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2318-2020.
Why was it recalled?
Distributed to the field without having completed design history files or design transfer activities
Which lots are affected?
Lot Number: 356280 (01)00887868134838(17)270716(10)356280; RM256H (01)00887868134838(17)260304(10)RM256H
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
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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