Recalls / —
—#152076
Product
XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system
- FDA product code
- ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device class
- Class 2
- Medical specialty
- Ear, Nose, Throat
- 510(k) numbers
- K965080
- Affected lot / code info
- All product shipped prior to 09/27/2016; DFU 18-0040; Part No. xMAX.
Why it was recalled
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Consignees were sent a recall notice via mail, dated 10/10/2016. In the notice, the firm notifies consignees of the Directions For Use (DFU) correction that will include recommended servicing intervals. All DFUs distributed after 09/28/2016 will have the correct DFU. The recalling firm instructs consignees to review the service intervals provided for product received, forward the notification to necessary parties and/or facilities, and complete the attached Verification Form. Complete Verification Forms are to be sent by fax to 877-546-5069 or by email to Anspach4870@stericycle.com. Consignees are also asked to maintain a copy of the notice for their records. Any questions can be directed to Customer Service at 1-800-327-6887, option 1.
Recalling firm
- Firm
- The Anspach Effort, Inc.
- Address
- 4500 Riverside Dr, Palm Beach Gardens, Florida 33410-4235
Distribution
- Distribution pattern
- Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Timeline
- Recall initiated
- 2016-10-06
- Terminated
- 2019-07-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #152076. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.