Food, drugs, devices › Medacta Usa Inc
Device recall: MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
FDA enforcement event 91947 is a device recall by Medacta Usa Inc of Memphis, TN, initiated 8 Mar 2023 and classified Class II, with 6 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Completed. Initiation: voluntary: firm initiated. Medacta Usa Inc has 12 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medacta Usa Inc, Memphis, TN.
Reason for recall
"There is a potential for breakage of the small screw used to affix the anti-backout plate."
Distribution
"US: ID, TX, GA, VA, AZ"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1400-2023 | MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device | 32 units | Class II | Completed | 26 Apr 2023 |
| Z-1401-2023 | MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device | 53 units | Class II | Completed | 26 Apr 2023 |
| Z-1402-2023 | MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device | 44 units | Class II | Completed | 26 Apr 2023 |
| Z-1403-2023 | MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device | 34 units | Class II | Completed | 26 Apr 2023 |
| Z-1404-2023 | MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device | 17 unis | Class II | Completed | 26 Apr 2023 |
| Z-1405-2023 | MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device | 50 units | Class II | Completed | 26 Apr 2023 |
Context
Other enforcement events for Medacta Usa Inc
All 12 events for Medacta Usa Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is a potential for breakage of the small screw used to affix the anti-backout plate."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: ID, TX, GA, VA, AZ"
Is the recall still ongoing?
FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.