A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone frag…
Tyber Medical · 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 Fibu…
Open FDA's page for this record- Cfres ID
- 212347
- Product res number
- Z-1213-2025
- Event date initiated
- 2025-01-21
- Event date posted
- 2025-02-21
- Recall status
- Open, Classified
- Res event number
- 96212
- Product code
- HRS
- Code info
- UDI-DI 00196449015566; Lot Numbers 265784, 24043BU01, 261290
- Firm FEI number
- 3012966183
- Recalling firm
- Tyber Medical
- Address 1
- 83 S Commerce Way Ste 310 83 S Commerce Way
- Address 2
- Ste 310
- City
- Bethlehem
- State
- PA
- Postal code
- 18017-8934
- Additional info contact
- Zachary Bloshuk 1-866-7610933
- Root cause description
- Process control
- Product quantity
- 214 units
- Distribution pattern
- Nationwide
- Product description
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone fragments to facilitate healing. Model/Catalog Number: 770708081
- 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
- 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 feedback@tybermed.com. 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 feedback@tybermed.com.
- K numbers
- K232652
- Harmonized identifiers (openFDA)
- Device name
- Plate, Fixation, Bone
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3030
- Device class
- 2
- K number
- K910482, K140814, K182201, K061211, K984390, K212608, K233873, K211051, K260323, K011335, K131445, K864924, K193452, K130340, K200538, K202914, K990392, K972913, K111008, K254002, K221465, K234062, K052624, K113648, K090047, K210198, K142943, K143697, K082624, K110908, K192675, K133536, K261892, K071549, K142484, K170780, K213005, K132554, K123203, K103243 +1,292 more
- Registration number
- 3011580264, 1226544, 3023265483, 9614438, 3007051929, 3006801265, 3010047402, 3007993775, 3013280419, 3038503572, 3014527928, 3019923333, 1058084, 3010400367, 9615766, 3010470577, 2032830, 3004187715, 3022777867, 3021336182, 2031009, 3015869121, 3011230048, 3043543260, 3011295718, 3026576110, 3010375065, 3010646402, 2531477, 3036756245, 3034676720, 1218017, 3010039400, 3013540005, 3011127597, 1828288, 1038671, 3005751028, 3027242374, 3009756327 +481 more
- FEI number
- 3011580264, 3023265483, 3007051929, 3006801265, 3010047402, 3007993775, 1000139987, 1000069183, 3013280419, 3038503572, 3007282753, 3014527928, 3019923333, 3002807231, 3002808264, 1000143502, 3003690049, 3010400367, 3010470577, 3004187715, 3022777867, 3008782585, 3021336182, 3015869121, 3011230048, 3043543260, 3011295718, 3026576110, 3010375065, 3010646402, 3002821504, 3036756245, 3034676720, 1218017, 3010039400, 3013540005, 3011127597, 1828288, 1038671, 3005751028 +481 more