Z-0447-2019Class II
Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System...
Zimmer GmbH / initiated 2018-10-02 / Terminated
Zimmer Biomet, Inc. began a recall of Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons... on . FDA classified it as Class II and gives the reason as "The set screw is not able to advance or reverse from the original position in the nail". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0447-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
- Product code
- HSB Rod, Fixation, Intramedullary And Accessories
- Reason for recall
- The set screw is not able to advance or reverse from the original position in the nail.
- FDA root cause
- Mixed-up of materials/components
- Action
- The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL LOT SPECIFIC" notification letters dated 10/2/18 to customers. The letters described the product, problem and actions to be taken. The customers were instructed to 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected] or fax to 574-372-4265 . This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. 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
- 2,163 in total (expanded)
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and foreign countries of: Chile, Costa Rica, Ecuador and Netherlands.
- Product codes and lots
- Lot number 371540
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0447-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0448-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0449-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0450-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0451-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0452-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0453-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0454-2019 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.