FDA Medical Device Recalls (openFDA)
Synthes USA HQ, Inc.: Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
- Recall number
- Z-1726-2013
- Recalling firm
- Synthes USA HQ, Inc.
- Product
- Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
- Status
- Terminated
- Initiated
- 2013-06-12
- Posted
- 2013-07-12
- Terminated
- 2015-09-21
- Reason
- The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.
- Root cause
- Nonconforming Material/Component
- Action
- SYNTHES sent an Urgent Notice: Medical Device Recall letter dated June 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to examine their inventory for affected product, remove it from use, and return it to Synthes. If they have affected product they were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of the letter and indicate the number of devices found and note the Return Authorization Number and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers did not have the affected product they were asked to complete the Verification Section and faxt to 610-251-9005. Customers with questions were instructed to call 610-719-5450 or e-mail FieldAction@synthes.com. For questions regarding this recall call 610-719-5450.
- Quantity
- 10
- Distribution
- Nationwide Distribution including PA, CT, DE, and NY.
- Lot, serial or model codes
- Part # 04.315.067 with lot #s 6184270 and/or 22612-04.
- 510(k) numbers
- ["K060138"]
- PMA numbers
- not on file
- Product code
- MQN
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28