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Terminated

VHS Pediatric Plate (for hip screw system) Ref 200501, VHS Pediatric Plate Stainless Steel Rx only, sterile

FDA Recall Z-0181-2007 · Posted 2006-11-15

Recalling FirmEBI, L.P.
Recall StatusTerminated
Product CodeKTT
Date Initiated2006-09-06
Date Terminated2007-02-21
Product Quantity363 in distributor inventory, 205 implanted, 352 plates in manufacturer's control

Reason for Recall

VHS Plate and lag screw components did not assemble correctly intraoperatively.

Firm Action

Recall notification was sent out by US mail on 9/6/2006 indicating the lot number(s) of product received.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011603VHS PEDIATRIC HIP SCREW SYSTEMWalter Abendschein, M.D. · 2001-08-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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