Recall Z-0895-2011 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Spine
Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the specified disc space; the t-handle can then be rotated clockwise expanding the distal paddle assembly to a specified height. Once the determined height has been achieved the t-hand
| Date | Jan 12, 2011 (initiated Dec 7, 2010) |
| Status | Terminated |
| Reason | Stryker Spine has received reports of the Disc Space Distractors failing during surgical procedures. |
| Root cause | Other |
| Action | Stryker Spine sent an URGENT PRODUCT RECALL letter dated December 7, 2010, via Fedex to all affected customers.. The letter identified the product, the problem, and the action they should take. Customers were instructed to examine their inventory and hospital locations to identify the product. Reconcile IBD Disc Space Distractors with the catalog and lot numbers referenced. Complete the Customer Response Form and distribution sheet and fax a copy of the Customer Response Form to Regulatory Compliance at 201-760-8370. Return the affected product using the enclosed pre-paid mailing label to |
| Quantity | 21 units |
| Distribution | Nationwide Distribution including AZ, FL, MA, NY, PA, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.