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Large Combination Clamp/Large External Fixation System… recallZ-0941-2013 · Synthes USA HQ, Inc. · initiated Jan 11, 2013

Class II Terminated All recalls posted in March 2013

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

The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Synthes sent an Urgent Notice: Medical Device Recall letter dated January 11, 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product(s), remove them from inventory and return them to Synthes. For questions call 610-719-5450 or email [email protected]

Recall details

Recall number
Z-0941-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 11, 2013
Posted by the FDA
Mar 11, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
136
Product code
KTT
FDA submissions
K082650
Distribution
USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA.

Product description

Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

Code information (models, lots, serial numbers)

Lot Numbers 6602070, 6582333, 6581191, and 6581193

Other devices under the same FDA submission

32 devices cleared under K082650 — 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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