Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a compone
FDA device recall Z-0574-2015 · posted 2014-12-12 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the use of an alternate method of screw removal, which could delay surgery up to 30 minutes.
- Action taken
- Consignees were sent via e-mail a Zimmer Spine "Medical Device Recall" letter dated August 26, 2013.The letter described the problem and the product affected by the recall. The letter described the "Required Action" to be taken by the consignees. Requested consignees to complete the Verification Section (Appendix A). For questions they can contact Zimmer Spine Customer Service at 1 (866) 774-6368 or spine.per@zimmer.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 14 devices
- Distribution
- US nationwide distribution.
- Date initiated
- 2013-08-26
- Date posted
- 2014-12-12
- Date terminated
- 2015-02-24
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM (K041808) | Endius, Inc. | 2004-10-01 |