Composite Series Skull Clamp, one clamp per tote. The MAYFIELD Skull Clamp (A3059) is a cranial stabilization device, de
FDA device recall Z-0210-2014 · posted 2013-11-13 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated. None of the complaints resulted in a report of patient injury, adverse health consequence, or a delay / prolongation of the surgical procedure.
- Action taken
- Integra sent an Urgent: Voluntary Medical Device Recall Notification dated August 29, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your local Integra NeuroSpecialist will set up a time with you to discuss replacement options but in the interim, Integra is asking that you do the following: 1. Review your inventory and determine if you have any MAYFIELD Composite Series Skull Clamps (A3059). If so, stop using them immediately and remove them from service to prevent any inadvertent use of the Composite Series Skull Clamp. Either while the Integra NeuroSpecialist is on-site or independently; 2. Complete the attached form. If you do not have affected product, check the box: I do not have Composite Series Skull Clamps. 3. If you do have affected product, check the box: I do have Composite Series Skull Clamps. Record the total quantity and Serial No.(s) of all Skull Clamps in your inventory. The Serial No. is located on the clamp upright comprised of two letters (SS) followed by six numerals. 4. Complete the other information and return by email or fax as indicated on the form, or give it to the Integra NeuroSpecialist who will return it for you. For assistance returning and exchanging these products or any other questions that you may have, please contact Integra Customer Service at 1-855-532-1723. We sincerely apologize for any inconvenience this may have caused and thank you for your cooperation.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HBL
- Quantity affected
- 37 units
- Distribution
- US Distribution including the states of AL, AR, CA, CT, FL, GA, IA, IL, MS, NY, OH, SC, TN, and TX.
- Date initiated
- 2013-08-29
- Date posted
- 2013-11-13
- Date terminated
- 2014-01-14
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAYFIELD SKULL CLAMP (K120633) | Integra LifeSciences Corporation | 2012-05-24 |