DePuy Spine, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0629-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy.

Product Classification:

Class II

Date Initiated: October 12, 2016

Date Posted: November 30, 2016

Recall Number: Z-0629-2017

Event ID: 75454

Reason for Recall:

SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Status: Terminated

Product Quantity: 21 units

Code Information:

Lot Codes: AGFB1H AGFB1V AGFBYK

Distribution Pattern:

US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated