CLASS II Device recall · Reported 14 Dec 2022 · FDA Enforcement Report
NextAR Shoulder Surgical Technique recalled by Medacta Usa
Medacta Usa is recalling NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based, distributed in 7 states. The recall was initiated on 27 Oct 2022 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-0372-2023
- FDA event ID
- 91091
- Recalling firm
- Medacta Usa, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Oct 2022
- FDA classified
- 2 Dec 2022
- Reported
- 14 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Hip & Knee Implants
Timeline
| 27 Oct 2022 | Recall initiated by company | |
| 2 Dec 2022 | Classified by FDA | +36 days |
| 14 Dec 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
Where it was distributed
AL, FL, NH, CO, IL, SC, AR
AlabamaArkansasColoradoFloridaIllinoisNew HampshireSouth Carolina
Stores named: Target
Questions about this recall
Why was it recalled?
A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.
Which lots are affected?
Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous
Where was it sold?
AL, FL, NH, CO, IL, SC, AR
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.
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