Z-1216-2025Class II
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended...
Tyber Medical / initiated 2025-01-21 / Open, Classified / root cause: manufacturing process
Tyber Medical began a recall of A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended forFixation of fractures of the distal tibia Model/Catalog... on . FDA classified it as Class II and gives the reason as "Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1216-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Tyber Medical
- Product
- A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770708102 Product Description:
- Product code
- HRS Plate, Fixation, Bone
- Reason for recall
- Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Tyber Medical issued Urgent Medical Device Recall letter on 1/24/25 via email to the Distributor. Letter states reason for recall, health risk and action to take: 1. Acknowledge the receipt of this communication via email correspondence to [email protected]. 2. Further distribute this communication to all applicable parties and/or customers that possess the impacted inventory. 3. Identify via laser-marked lot number and quarantine the impacted plates under Zimmer Biomet s control that have not been distributed for sale. An RMA will be provided for the return of goods to Tyber Medical for further inspection. 4. Identify via laser-marked lot number and quarantine the impacted plates that have been distributed. An RMA will be provided for the return of goods to Tyber Medical for further inspection. 5. Complete the customer response form located in Appendix 2 and return it to Tyber Medical via email correspondence to [email protected].
- Quantity in commerce
- 219 units
- Distribution
- Nationwide
- Product codes and lots
- UDI-DI 00196449015597; Lot Numbers 265810, 260892, 262559
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1209-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1210-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1211-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1212-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1213-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1214-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1215-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1216-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1217-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1218-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1219-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1220-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1221-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1222-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1223-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1224-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1225-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1226-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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