Z-2744-2015Class II
Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440
Highridge Medical, LLC / initiated 2015-08-05 / Terminated / root cause: labeling and UDI
Biomet Spine, LLC began a recall of Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440 on . FDA classified it as Class II and gives the reason as "Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-2744-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Highridge Medical, LLC
- Product
- Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
- Product code
- KWQ Appliance, Fixation, Spinal Intervertebral Body
- Reason for recall
- Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.
- Root cause tag
- labeling and UDI
- FDA root cause
- Labeling mix-ups
- Action
- Zimmer Biomet sent an Urgent Medical Device Recall Notice dated August 5, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by customer. Customers were instructed to immediately locate and discontinue use of the affected product. This action requires the immediate location and discontinued use of the item and its immediate return to Zimmer Biomet Spine. Specifically, customers were REQUIRED to take the following steps: " Immediately locate and remove from circulation the items consigned/loaned to your account as identified on page two of this notice. " Carefully follow the instructions on the enclosed "Response Form". " If you have further distributed these items to medical facilities, you MUST notify them of this action. This letter MUST be given to the person responsible for receiving recall notices. However, you are charged with the location and return of these items. Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone: Online: Fax: Phone: Regular Mail: www. fda .gov /MedWatch/report.htm (800) FDA-0178 (800} FDA-1088 Use postage-paid FDA form 3500 available at www.fda.gov/Medwatch/getforms.htm and mail to Medwatch, 5600 Fishers Lane, Rockville, MD 20852-9787. Questions related to this notice should be directed to 303-501-8400 Monday through Friday, 8 a.m.to 5 p.m. MST. Zimmer Blomet
- Quantity in commerce
- 7 parts
- Distribution
- Nationwide Distribution including Distributed nationwide to OH, LA, TX, and GA.
- Product codes and lots
- Model Number 14-521614B, lot number 375440.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2744-2015 | Class II | Terminated | Voluntary: Firm initiated |
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