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Synthes Spine Zero-P Instruments and Implants recallZ-0104-2012 · Synthes USA (HQ), Inc. · initiated Sep 23, 2011

Terminated All recalls posted in October 2011

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Synthes USA (HQ), Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK-CR is utilized as a cervical interbody spacer. PEEK-CR is not currently indicated for use as a cervical interbody spacer.

FDA root cause category: Labeling False and Misleading

What the company is doing

Synthes (USA) sent an "URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated September 23, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review the updated supplemental labeling page included with the letter and replace/attach the technique guide page in any Zero-P technique guide that customers may have. The Verification Section of the letter is to be completed and returned to Synthes via fax at 610-251-9005. For questions regarding this notice call 1-800-620-7025 ext. 5403.

Recall details

Recall number
Z-0104-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 23, 2011
Posted by the FDA
Oct 21, 2011
Recalling firm
Synthes USA (HQ), Inc.
Product code
ODP
FDA submissions
K072981, K093762
Distribution
USA (nationwide) including Puerto Rico, Washington, DC and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.

Product description

Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device.

Code information (models, lots, serial numbers)

N/A - Labeling Correction

Other devices under the same FDA submission

6 devices cleared under K072981, K093762 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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