Z-3073-2018Class II
Affixus Hip Fracture Nail Right 125 13 mm x 380 mm, Item Number: 814313380
Zimmer GmbH / initiated 2018-07-17 / Terminated
Zimmer Biomet, Inc. began a recall of Affixus Hip Fracture Nail Right 125 13 mm x 380 mm, Item Number: 814313380 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-3073-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Affixus Hip Fracture Nail Right 125 13 mm x 380 mm, Item Number: 814313380
- 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
- Under Investigation by firm
- Action
- On 7/17/18, Urgent Medical Device Recall letters were sent to Risk Managers and Distributors. The letters instructed customers to do the following: Risk Manager Responsibilities: 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]. 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]. Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. Request a Return Authorization Number through Fast SMS or by emailing [email protected] c. For each return, send a copy of Attachment 1 to [email protected]. d. Include a hardcopy of Attachment 1 in each carton of
- Quantity in commerce
- 5947 total
- Distribution
- The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.
- Product codes and lots
- 482620 501270 813390
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-3046-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3047-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3048-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3049-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3050-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3051-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3052-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3053-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3054-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3055-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3056-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3057-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3058-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3059-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3060-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3061-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3062-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3063-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3064-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3065-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3066-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3067-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3068-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3069-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3070-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3071-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3072-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3073-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3074-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3075-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3076-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3077-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3078-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3079-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3080-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3081-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3082-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3083-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3084-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3085-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3086-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3087-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3088-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3089-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3090-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3091-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3092-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3093-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3094-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3095-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3096-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3097-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3098-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3099-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3100-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3101-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3102-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3103-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3104-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3105-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3106-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3107-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3108-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3109-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3110-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3111-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3112-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3113-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3114-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3115-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3116-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3117-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3118-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3119-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3120-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3121-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3122-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3123-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3124-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3125-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3126-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3127-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3128-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3129-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3130-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3131-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3132-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3133-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3134-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3135-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3136-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3137-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3138-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3139-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3140-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3141-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3142-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3143-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3144-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3145-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3146-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3147-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3148-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3149-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3150-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3151-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3152-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3153-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3154-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3155-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3156-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3157-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3158-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3159-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3160-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3161-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3162-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3163-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3164-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3165-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3166-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3167-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3168-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3169-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3170-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3171-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3172-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3173-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3174-2018 | 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.