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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72962

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 10, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
OrthoPediatrics Corp

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Z-0622-2016
Recall number
Z-0622-2016
Initiated
November 10, 2015
Classification
Class II
Status
Terminated
Recalling firm
OrthoPediatrics Corp
Quantity
102

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.

Code information

Item number; lot; product description 00-1300-1735; 44003; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 35MM. 00-1300-0735; 44601; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM. 00-1300-0740; 44602; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0740; 43926; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0740; 44252; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0745; 43927; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM. 00-1300-0750; 44619; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 50MM. 00-1300-0620; 44623; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 20MM. 00-1300-0640; 44617; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM. 00-1300-0640; 44884; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM. 00-1300-1745; 44005; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 45MM. 00-1300-0635; 44677; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 35MM.

Distribution pattern

US Distribution to states of: AL, AZ, CA, DE, FL, GA, HI, KY, LA, MI, MO, MN, MS, NC, NJ, NY, OH, OR, TN, and TX.