Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo… recallZ-0135-2007 · DePuy Spine, Inc. · initiated Oct 10, 2006

Terminated All recalls posted in November 2006

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from DePuy Spine, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Sterility of device is compromised due to loss of package integrity

FDA root cause category: Other

What the company is doing

DePuy Spine notified US consignees by letter via FedEX on 10/10/06 addressed to Materials Management. Outside the US noitifcation made to DePuy Spine and Distributors, recalls will be conducted by the foreign subsidiaries.

Recall details

Recall number: Z-0135-2007
Recall class: Not yet classified by the FDA
Status: Terminated
Initiated by the company: Oct 10, 2006
Posted by the FDA: Nov 2, 2006
Recalling firm: DePuy Spine, Inc.
Quantity: 2272 units
Product code: HWC
FDA submissions: K915800, K993099
Distribution: Nationwide and Australia, New Zealand, Germany, Canada, Czech Republic, Netherlands, Portugal, Sweden, UK, Japan, Indonesia, Italy, Belgium, Hong Kong, Poland, Spain, Switzerland, Taiwan, Turkey, Chile, Egypt, Guatemala, Hungary, Israel, Greece, Thailand, Mexico, Colombia, Venezuela, Slovenia

Product description

Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Code: HT025HI

Code information (models, lots, serial numbers)

All lot numbers except those beginning with '6' or ending with the letter 'R'

Other devices under the same FDA submission

1 device cleared under K915800, K993099 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

BREMER 3D HALO CROWN 292301001
Depuy Spine, LLC · COMPONENT, TRACTION, INVASIVE
2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 36504).

Z-0130-2007 · Terminated
DePuy Spine Bremer 3-D Halo Crown System Product Code: 2923-01-100
Z-0131-2007 · Terminated
0 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-010
Z-0132-2007 · Terminated
12 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-020
Z-0133-2007 · Terminated
Small Halo Crown, DePuy Spine Bremer Halo System Product Number: HT025
Z-0134-2007 · Terminated
Large Halo Crown, DePuy Spine Bremer Halo System Product Number: HT026
Z-0136-2007 · Terminated
Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Number: HT026HI
Z-0137-2007 · Terminated
Adjustable Ring Traction Set, Size B, DePuy Spine Bremer Halo System Product Code: HT001
Z-0138-2007 · Terminated
Adjustable Ring Traction Set, Size C, DePuy Spine Bremer Halo System Product Code: HT002
Z-0139-2007 · Terminated
Small Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT001
Z-0140-2007 · Terminated
Large Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT002
Z-0141-2007 · Terminated
Standard Skull Rings, DePuy Spine Bremer Halo System Product Code: AC007
Z-0142-2007 · Terminated
Skull pins w/Torque, DePuy Spine Bremer Halo System Product Code: AC014
Z-0143-2007 · Terminated
Extra Long Skull Pins, DePuy Spine Bremer Halo System Product Number: AC018
Z-0144-2007 · Terminated
HI Fix Skull Pins, DePuy Spine Bremer Halo System Product Code: AC020

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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