—#122581

Product

Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: part no. 396.396 (lot nos. T989765 and T989780), part no. 03.632.087 (lotT987270), part no. 03.812.005 (lot nos. T987734, T988931, and T987623), and part no. 03.820.129 (lot no. T988206).

Why it was recalled

One material batch used for production of the affected parts of the Synthes Material Mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

SYNTHES sent an Urgent Notice: Medical Device Recall letter dated October 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers 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 by checking the appropriate box indicating affected product was located. Customers were also asked to indicate the number of devices found and note the Return Authorization Number. Return the Verification Form with the product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers should also return the Verification Form if no affected product was found in their inventory. Return all documents to Synthes by fax: 888-679-4875 or Scan/email: FieldAction@synthes.com Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Worldwided Distribution: USA (nationwide) including IL, MO, TX, WA and Internationally to Canada and Switzerland.

Timeline

Recall initiated: 2013-10-15
Posted by FDA: 2013-11-26
Terminated: 2015-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122581. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.