Z-2126-2018Class II
CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b)...
Orthofix SRL / initiated 2018-04-06 / Terminated / root cause: design
Orthofix, Inc began a recall of CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030) on . FDA classified it as Class II and gives the reason as "Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2126-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Orthofix SRL
- Product
- CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)
- Product code
- HRS Plate, Fixation, Bone
- Reason for recall
- Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
- Quantity in commerce
- 24
- Distribution
- U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
- Product codes and lots
- (UDI)/Lot: a) (18056099647694) B1099067; b) (18056099647700) B1099061; c) (18056099647717) B1099063
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2116-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2117-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2118-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2119-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2120-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2121-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2122-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2123-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2124-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2125-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2126-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2127-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2128-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2129-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2130-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2131-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2132-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2133-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2134-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2135-2018 | Class II | Terminated | Voluntary: Firm initiated |
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