Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusabl
FDA device recall Z-2759-2015 · posted 2015-09-10 · Terminated
Recall details
- Recalling firm
- Biomet Spine, LLC
- Reason for recall
- Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.
- Action taken
- The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated 7/23/2015 to their Consignees/Customers via certified letter. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of device; remove from circulation; carefully follow instructions on enclosed "Response Form" and complete and return via fax to 303.501.8444; if you have further distributed these devices to medical facilities, you MUST notify them of this action; and return device and form to Zimmer Biomet Spine, 310 Interlocken Pkwy, Ste 120, Broomfield, CO 80021. Questions related to this notice should be directed to the Quality Engineer at 303-501-8457 Monday through Friday, 8 a.m. to 5 p.m. MST.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 49
- Distribution
- Worldwide Distribution: US (nationwide) in states of: NY, MO, WI, IN, CA, NC, and OH, and to countries of: Japan and Netherlands.
- Date initiated
- 2015-07-22
- Date posted
- 2015-09-10
- Date terminated
- 2015-12-10
- Location
- Broomfield, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEXTGEN ALTIUS OCT SYSTEM (K122378) | Biomet Spine (Aka Ebi, LLC) | 2012-09-20 |