Z-0161-2019Class II
Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360
Zimmer GmbH / initiated 2018-08-08 / Terminated / root cause: manufacturing process
Zimmer Biomet, Inc. began a recall of Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures on . FDA classified it as Class II and gives the reason as "There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0161-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures
- Product code
- HSB Rod, Fixation, Intramedullary And Accessories
- Reason for recall
- There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- Root cause tag
- manufacturing process
- FDA root cause
- Employee error
- Action
- Urgent Medical Device Recall notification letters dated 8/8/18 were sent to customers. The letters identified the affected products, problem and actions to be taken. Customers were instructed to: 1. Complete the Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. 2. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]
- Quantity in commerce
- 44
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Chile, Netherlands.
- Product codes and lots
- Lot Numbers: 343590 343610
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0122-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0123-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0124-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0125-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0126-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0127-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0128-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0129-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0130-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0131-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0132-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0133-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0134-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0135-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0136-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0137-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0138-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0139-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0140-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0141-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0142-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0143-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0144-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0145-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0146-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0147-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0148-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0149-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0150-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0151-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0152-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0153-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0154-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0155-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0156-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0157-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0158-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0159-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0160-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0161-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0162-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0163-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0164-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0165-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0166-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0167-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0168-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0169-2019 | Class II | Terminated | Voluntary: Firm initiated |
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