Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, ped
FDA device recall Z-1512-2015 · posted 2015-04-22 · Terminated
Recall details
- Recalling firm
- X Spine Systems Inc
- Reason for recall
- One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
- Action taken
- The firm, X-spine Systems, Inc., sent an "Urgent Medical Device Recall" letter dated March 19, 2015 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to notify affected hospital and surgeon of the recall immediately; complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately via mail: 725 Alexandersville Road, Miamisburg OH 45342-RMA #5288; and No action should be taken with product that has been implanted. Please contact customer service at 800.903.0640 or email orders@x-spine.com with any questions.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MNH
- Quantity affected
- 14 units
- Distribution
- US Distribution to states of: KS, NV & TX.
- Date initiated
- 2015-03-11
- Date posted
- 2015-04-22
- Date terminated
- 2015-10-21
- Location
- Miamisburg, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FORTEX PEDICLE SCREW SYSTEM (K120832) | X-Spine Systems, Inc. | 2012-10-23 |